The post VP Laboratory Systems Regulatory Affairs appeared first on World News: Entertainment, lifestyle, Health, Technology.
]]>Job description: Job Description:
Do you want to join us in helping to fight the world’s most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere.
We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting? Then come and join our global team as VP, Laboratory Solutions Regulatory Affairs to drive the execution of our global regulatory strategy.
Our global team: We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.
Our culture: We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success. Check our Careers Site at .
This is a role well suited to an ambitious professional, looking for the next step in their career. As a VP Laboratory Solutions Regulatory Affairs you will be responsible for:
This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers
Required skills to have for the success of this role
The pay range for this position is $214,856 – $295,427 annually; however, base pay offered may vary depending on job-related knowledge, skills, and experience. The annual incentive target is 30% of base pay. Siemens Healthineers offers a variety of health and wellness benefits including paid time off and holiday pay. Details regarding our benefits can be found here:
This information is provided per the required state Equal Pay Act. Base pay information is based on market location. Applicants should apply via Siemens Healthineers external or internal careers site.
At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.
Beware of Job Scams
Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the .
If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers.
If you wish to find out more about the specific before applying, please visit: .
“Successful candidate must be able to work with controlled technology in accordance with US export control law.” “It is Siemens Healthineers’ policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.”
As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.
Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.
EEO is the Law
Applicants and employees are protected under Federal law from discrimination. To learn more, .
Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, .
California Privacy Notice
California residents have the right to receive additional notices about their personal information. To learn more, click .
Expected salary:
Location: Tarrytown, NY
Job date: Wed, 25 Oct 2023 23:54:03 GMT
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]]>The post Regulatory Coordinator – Days – 8:00AM to 5:00PM appeared first on World News: Entertainment, lifestyle, Health, Technology.
]]>Job description: *ALL APPLICATIONS MUST INCLUDE COVER LETTER AND RESUME TO BE CONSIDERED*
LSI SOLUTIONS® founded in 1986, located in beautiful Victor, New York, is a dynamic and growing medical device company with over 500 employees dedicated to advancing minimally invasive surgical instruments through research, development, manufacturing, and marketing. We have doubled in size in just the last 4 years! The LSI Campus includes 10 buildings (170,000+ sq ft) on 95 meticulously cared for acres.
We are searching for passionate people looking to make a difference in the medical device industry. By joining LSI SOLUTIONS® an ISO 13485 certified company, you will become part of as energetic team working together to relentlessly pursue better patient outcomes with state-of-the-art devices. After all, our ultimate customer is the patient.
POSITION TITLE: Regulatory Coordinator
HOURLY PAY RANGE: $24.00 – $38.00
POSITION HOURS: 8:00AM – 5:00PM
POSITION LOCATION: Onsite at LSI Solutions in Victor, NY
REGULATORY COORDINATOR JOB SUMMARY:
The Regulatory Coordinator is responsible for supporting various activities on the Regulatory Team, including administration of LSI’s complaint handling system, and assisting with the procurement of domestic and international regulatory approval for new and revised product lines, helping to gather regulatory intelligence regarding updates to U.S. and international medical device regulations, and supporting Rest-of-World (ROW) regulatory approvals, while maintaining full Quality and Regulatory compliance with all standards that govern the design, development, manufacturing, and distribution of our medical devices.
REPORTS TO: REGULATORY COORDINATOR ESSENTIAL FUNCTIONS:
Level I
Level II
Level III
Regulatory Coordinator Team Lead
REGULATORY COORDINATOR EDUCATION & EXPERIENCE:
Level I
Level II
Level III:
Regulatory Coordinator Team Lead:
REGULATORY COORDINATOR KNOWLEDGE, SKILLS & ABILITIES:
REGULATORY COORDINATOR PHYSICAL DEMANDS AND WORK ENVIRONMENT:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
LSI SOLUTIONS BENEFITS INCLUDE:
LSI SOLUTIONS® is an equal opportunity employer and does not discriminate based on any legally protected status or characteristic.
Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran.
Expected salary:
Location: Victor, NY
Job date: Sat, 28 Oct 2023 01:26:26 GMT
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]]>The post Healthcare Regulatory Administrator (O-5 Billet) Non-Supervisory appeared first on World News: Entertainment, lifestyle, Health, Technology.
]]>Job description: Summary
This position is located within the Department of Homeland Security (DHS), Immigration and Customs Enforcement (ICE), Enforcement and Removal Operations (ERO), ICE Health Service Corps (IHSC), Office of the Assistant Director. The incumbent supports the Assistant Director by providing advice on a range of issues that overlap medical, legal, and policy domains. The incumbent will report directly to the IHSC Chief of Staff (CoS). This is a non-supervisory position.
Overview
Open & closing dates
10/02/2023 to 10/01/2024
Salary
$1 – $150,000 per year
Please note that the salary is dependent on the officer’s rank, years in service, and location of duty station.
Pay scale & grade
CC 5
Location
1 vacancy in the following location:
Remote job
No
Telework eligible
No
Travel Required
Occasional travel – You may be expected to travel for this position.
Relocation expenses reimbursed
Yes-You may qualify for reimbursement of relocation expenses in accordance with agency policy.
Appointment type
Permanent –
Work schedule
Full-time –
Service
Excepted
Promotion potential
None
Job family (Series)
Supervisory status
No
Security clearance
Drug test
Yes
Position sensitivity and risk
Trust determination process
Announcement number
DE-12123341-23-LE
Control number
752472000
This job is open to
Clarification from the agency
Applicants must be either a current USPHS Commissioned Corps Officer or a USPHS Call to Active Duty (CAD) candidate.
Videos
Duties
DUTIES AND RESPONSIBILITIES: * Must have a demonstrated ability to learn new areas of regulatory law and advise clients with a high level of professionalism.
Requirements
Conditions of Employment
Qualifications
PHYSICAL DEMANDS: * Sitting and/or standing for extended periods of time (6-8 Hours).
Education
REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES: * Must possess a Juris Doctorate (J.D.) from an accredited American Bar Association law school. Additional education or degrees in a health profession discipline or program management experience is desirable.
Additional information
MEMORANDUM OF AGREEMENT:
U.S. Public Service Commissioned Corps officers are detailed to Department of Homeland Security as described in a Memorandum of Agreement.
SUPERVISORY CONTROLS:
The Healthcare Regulatory Administrator works under the general supervision of the IHSC Chief of Staff.
A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. .
Expected salary: $150000 per year
Location: Washington DC
Job date: Sun, 08 Oct 2023 02:05:07 GMT
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]]>The post Tax & Regulatory Services- Experienced Hire appeared first on World News: Entertainment, lifestyle, Health, Technology.
]]>Job description: Company Description
Deloitte is the largest private professional services network in the world. Everyday, approximately 312,000 professionals in more than 150 countries demonstrate their commitment to making an impact that matters.
Our West Africa practice serves multinationals, large national enterprises, small and medium-sized enterprises and the public sector across Nigeria and Ghana.
In Nigeria, Deloitte is one of the leading professional services firms, specializing in providing Audit, Tax, Consulting, Risk Advisory and Financial Advisory services. We serve clients in a variety of industries from financial services, consumer, telecommunications, media & technology, energy resources & Industrial and government and public services.
Our professionals are unified by a collaborative culture that fosters integrity, outstanding value to markets and clients, commitment to each other, and strength from cultural diversity. They are committed to strengthening corporate responsibility, building public trust, and making a positive impact in their communities. We understand that our professionals hold interests outside of the work space and we aim to encourage work/life balance, supporting them in all aspects of their lives.
Our talented professionals and our clients understand the link between a strong learning and development programme and the ability for Deloitte to deliver on its promise of consistent, high-quality service delivery worldwide.
Whatever your age, gender or culture, take your career to the next level with the talents and capabilities you will develop at Deloitte.
About Tax & Regulatory Services
Deloitte offers clients a broad range of fully integrated tax services. Our approach combines insight and innovation from multiple disciplines with business and industry knowledge to help your company excel globally.
Our Services
Service lines opportunity openings:
Business Tax
Transfer Pricing
Job Description
We are seeking experienced hires with expertise in Business Tax and Transfer Pricing to join our Tax & Regulatory Services unit.
Responsibilities
Required Skills
Business Tax
Transfer Pricing
Qualifications
Additional Information
Our promise to our people: Deloitte is where potential comes to life.
Be yourself, and more.
We are a group of talented people who want to learn, gain experience, and develop skills. Wherever you are in your career, we want you to advance.
You shape how we make impact.
Diverse perspectives and life experiences make us better. Whoever you are and wherever you’re from, we want you to feel like you belong here. We provide flexible working options to support you and how you can contribute. Be the leader you want to be.
Be the leader you want to be.
Some guide teams, some change culture, some build essential expertise. We offer opportunities and experiences that support your continuing growth as a leader.
Have as many careers as you want.
We are uniquely able to offer you new challenges and roles – and prepare you for them. We bring together people with unique experiences and talents, and we are the place to develop a lasting network of friends, peers, and mentors. Our TVP is about relationships – between leaders and their people, the firm and its people, peers, and within in our communities.
Duration: 2 weeks
Application deadline: Friday, 29 December 2023
At Deloitte, we want everyone to feel they can be themselves and to thrive at work—in every country, in everything we do, every day. We aim to create a workplace where everyone is treated fairly and with respect, including reasonable accommodation for persons with disabilities. We seek to create and leverage our diverse workforce to build an inclusive environment across the African continent.
Expected salary:
Location: Lagos, Lagos State
Job date: Sat, 16 Dec 2023 23:33:07 GMT
The post Tax & Regulatory Services- Experienced Hire appeared first on World News: Entertainment, lifestyle, Health, Technology.
]]>The post Tax & Regulatory Services- Experienced Hire appeared first on World News: Entertainment, lifestyle, Health, Technology.
]]>Job description: Company Description
Deloitte is the largest private professional services network in the world. Everyday, approximately 312,000 professionals in more than 150 countries demonstrate their commitment to making an impact that matters.
Our West Africa practice serves multinationals, large national enterprises, small and medium-sized enterprises and the public sector across Nigeria and Ghana.
In Nigeria, Deloitte is one of the leading professional services firms, specializing in providing Audit, Tax, Consulting, Risk Advisory and Financial Advisory services. We serve clients in a variety of industries from financial services, consumer, telecommunications, media & technology, energy resources & Industrial and government and public services.
Our professionals are unified by a collaborative culture that fosters integrity, outstanding value to markets and clients, commitment to each other, and strength from cultural diversity. They are committed to strengthening corporate responsibility, building public trust, and making a positive impact in their communities. We understand that our professionals hold interests outside of the work space and we aim to encourage work/life balance, supporting them in all aspects of their lives.
Our talented professionals and our clients understand the link between a strong learning and development programme and the ability for Deloitte to deliver on its promise of consistent, high-quality service delivery worldwide.
Whatever your age, gender or culture, take your career to the next level with the talents and capabilities you will develop at Deloitte.
About Tax & Regulatory Services
Deloitte offers clients a broad range of fully integrated tax services. Our approach combines insight and innovation from multiple disciplines with business and industry knowledge to help your company excel globally.
Our Services
Service lines opportunity openings:
Business Tax
Transfer Pricing
Job Description
We are seeking experienced hires with expertise in Business Tax and Transfer Pricing to join our Tax & Regulatory Services unit.
Responsibilities
Required Skills
Business Tax
Transfer Pricing
Qualifications
Additional Information
Our promise to our people: Deloitte is where potential comes to life.
Be yourself, and more.
We are a group of talented people who want to learn, gain experience, and develop skills. Wherever you are in your career, we want you to advance.
You shape how we make impact.
Diverse perspectives and life experiences make us better. Whoever you are and wherever you’re from, we want you to feel like you belong here. We provide flexible working options to support you and how you can contribute. Be the leader you want to be.
Be the leader you want to be.
Some guide teams, some change culture, some build essential expertise. We offer opportunities and experiences that support your continuing growth as a leader.
Have as many careers as you want.
We are uniquely able to offer you new challenges and roles – and prepare you for them. We bring together people with unique experiences and talents, and we are the place to develop a lasting network of friends, peers, and mentors. Our TVP is about relationships – between leaders and their people, the firm and its people, peers, and within in our communities.
Duration: 2 weeks
Application deadline: Friday, 29 December 2023
At Deloitte, we want everyone to feel they can be themselves and to thrive at work-in every country, in everything we do, every day. We aim to create a workplace where everyone is treated fairly and with respect, including reasonable accommodation for persons with disabilities. We seek to create and leverage our diverse workforce to build an inclusive environment across the African continent.
Expected salary:
Location: Lagos, Lagos State
Job date: Sun, 17 Dec 2023 00:58:50 GMT
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]]>The post Senior Regulatory Affairs Specialist – Hybrid appeared first on World News: Entertainment, lifestyle, Health, Technology.
]]>Job description: Job Description Summary As Senior Regulatory Affairs Specialist, you will be primarily focused on maintaining continued market access and providing regulatory support for new product development projects.
Job Description
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.
In BD Specimen Management (BD SM), we develop some of the most widely used products in the field of specimen collection including acquisition of the sample, collection into an appropriate container, and also emerging point-of-care applications. Our team has the unique opportunity to be involved with both medical devices and in vitro diagnostics allowing you to broaden your expertise and grow in your career.
Key responsibilities will include:
Coordinate, prepare, and execute premarket applications to the US FDA including Premarket Notification [510(k)], Pre-Sub, IDE, PMA, and De Novo submissions in a timely manner. Act as liaison with FDA regarding product submissions.
Assess necessity for submitting a 510(k) application for proposed device modifications. Prepare robust non-filing justifications for changes that do not require a 510(k) submission.
Coordinate and prepare technical files for submission to European Notified Bodies for timely CE marking of new and modified products, with appropriate input from supporting functions (R&D, Quality, Manufacturing, Medical Affairs, etc.).
Represent RA and demonstrate leadership in complex product development teams by identifying and interpreting relevant regulatory requirements, and providing actionable regulatory guidance throughout the product development cycle prior to regulatory submission.
Identify and communicate appropriately quantified risks and mitigation approaches associated with regulatory strategies to stakeholders.
Support development and execution of global regulatory strategies by collaborating closely with international regulatory associates to register our devices worldwide.
Lead regulatory efforts required to comply with new regulations (e.g., EU MDR/IVDR, MDSAP) and other requirements including changes to international standards.
Review and approve product labeling, promotional materials, and advertising materials to ensure regulatory compliance.
Review clinical and human factors protocols/reports to assure collection of appropriate data for regulatory submissions and regulatory compliance. Engages with Medical Affairs in the development and approval of Clinical Evaluation Report to assure the documents meet regulatory requirements.
Ensures FDA device listings and facility registrations are maintained.
Request FOI information and maintain FOI files in alignment with business strategies.
Develop and maintain standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards.
Coordinate and respond to requests for product information, and questionnaires requested by customers.
Represent BD in relevant external trade organizations and lead/participate in regulatory standards development/compliance activities as necessary to support BD’s continuous product development and compliance efforts.
Remain current on regulations affecting BD products (EU MDR/IVDR, reclassification activities, etc.) and keep the relevant team and supervisors informed about potential impact.
Identify ways to improve the efficiency of current work process and execute them.
Carry out the above tasks with limited supervision.
About you: To be successful in this role, you require:
Minimum bachelor’s degree in a technical discipline (e.g., engineering, bioengineering, biology, chemistry). Advanced degree preferred.
Minimum 3 or more years Regulatory Affairs or Quality experience in medical device or in vitro diagnostic device companies.
Demonstrated ability to resolve problems and to make appropriate regulatory decisions under pressure.
Demonstrated success in the preparation and completion of regulatory submissions (PMA, 510(k), IDE to FDA and other global regulatory agencies.
Experience in negotiating with regulatory authority personnel (e.g. FDA, Notified Bodies) in medical device and in vitro diagnostic areas.
International product registration experience preferred.
Demonstrated global perspective, customer focus, cross-functional collaboration and teamwork skills.
Comprehensive knowledge of US medical device regulations, 21 CFR 820 -Quality System Regulation, and standards, FDA guidance documents, Good Clinical Practice standards, Good Laboratory Practice regulations.
Current knowledge of European quality system standards, and requirements under the medical device directive MDD 93/42/EEC and IVD directive IVDD 98/79/EC. Knowledge of EU MDR and IVDR preferred.
This is a hybrid position where the candidate is required to be in the office a minimum of 3 days a week. Office location is either Franklin Lakes, NJ or Sparks, MD.
**This position does not offer relocation assistance**
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
PDN
Primary Work Location USA NJ – Franklin Lakes
Additional Locations USA MD – Sparks – 26 Loveton Circle
Work Shift
Expected salary:
Location: Franklin Lakes, NJ
Job date: Thu, 16 Nov 2023 03:04:13 GMT
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]]>The post PRA – Regulatory Engagement; Head of UK/EU Compliance and Regulatory Engagement appeared first on World News: Entertainment, lifestyle, Health, Technology.
]]>Job description: Job Title:– PRA – Regulatory Engagement; Head of UK/EU Compliance and Regulatory Engagement
Division: Compliance
Reports To: Group Head of Compliance
Key Relationships: Group Head of Compliance, Global Compliance, US Compliance, Regulatory Engagement Team, UK, EU and US Compliance Staff, Underwriters, Finance, Internal Audit, Culture & People, Delegated Authorities team, Risk Management.
PRA Supervisors and PRA staff; Other regulators including Lloyd’s of London, Financial Conduct Authority, Central Bank of Ireland, Connecticut Insurance Department, senior personnel, outside legal counsel
Job Summary: Lead on oversight and control of PRA compliance matters, manage and oversee Beazley regulatory relationships and engagement, oversee UK and EU compliance requirements. Ensure effective oversight of all PRA compliance matters is in place and provide a framework and structure that supports regulatory compliance across the Group as it grows in size and complexity. Ensure similar compliance structures in place for other regulatory requirements and relationships. Manage and oversee other regulatory team members, including Lloyd’s of London and Central Bank of Ireland. Support other parts of the Group Compliance function as required. Role may be subject to FCA Conduct Rules.
Key Responsibilities
§ Regulatory Engagement: Primarily responsible for managing, developing, maintaining and ensuring there continue to be strong and effective regulatory relationships with key regulators, including the PRA, Lloyd’s of London, Central Bank of Ireland. Responding and delivering key PRA requirements and managing the PRA regulatory cycle, including actions arising from PSM Letter, monthly regulatory supervisory meetings, ad hoc regulatory meetings, general PRA requests, thematic reviews, questionnaires, discussion or consultation papers. Supporting Group Head of Compliance on related regulatory issues and workstreams, including with supporting internal senior stakeholders and Executives with regulatory interactions. Manage deliverables from the PRA PSM letter, targeted regulatory reviews, thematic reviews and information requests. Provide oversight of regulatory returns processes to support their timely and accurate submission.
§ PRA compliance subject matter expert: Ensure compliance with PRA requirements, and other relevant legislation. Liaise with internal stakeholders and senior management to support the group to achieve growth ambitions effectively and compliantly. Support internal stakeholders on issues arising relevant to the PRA. Design and conduct training on relevant regulatory matters.
§ Horizon scanning: Monitor and review PRA and other relevant regulators’ insurance legislation, initiatives and proposals which may impact on the firm’s businesses.
§ Regulatory change: Manage compliance and regulatory projects, including assessing the impact of new legislation and regulations on the relevant legal entities and preparing for their implementation. Support First Line of Defence risk owners in implementing frameworks, policies, procedures, processes and systems.
§ Stakeholder management: Build effective partnerships with internal and external stakeholders, supporting the Group Head of Compliance and other parts of the Compliance function. Liaise closely with Compliance Managers supporting Lloyd’s and CBI relationship.
§ Governance and assurance: Prepare internal reporting and present to boards and committees of Beazley entities. Develop and document MI and procedures to ensure effective governance within the Compliance function.
§ Strategy, leadership and management: Provide strategic-level expertise to senior management. Support Group Head of Compliance with developing and implementing Compliance Function strategy and compliance plan, including resourcing requirements. Identify and implement automated solutions to continually enhance compliance processes. Direct line management responsibilities. Guide and support development of team members, maintaining an inclusive, proactive culture.
§ Risk Management: Develop and maintain MI to support compliance KRIs within risk management framework, working to ensure Beazley acts within defined regulatory risk appetite. Design and implement relevant compliance risk assessments.
§ Brand champion: Build Beazley’s brand with the PRA and other relevant regulatory authorities as a well-run, ethical and sustainable company. Representing Beazley at relevant insurance market forums, committees and events.
General
It is important that within all your interactions both internally and externally you adhere to Beazley’s core values – Being Bold, Striving for Better, and Doing the Right Thing as they contribute to an internal environment of teamwork and promote a positive brand image and experience to our external customers.
We also expect Beazley employees to:
§ Comply with Beazley procedures, policies and regulations including the code of conduct
§ Undertake training on Beazley policies and procedures as delivered by your line manager, the Culture & People or assurance teams (compliance, risk, internal audit) either directly, via e-learning or the learning management system
§ Display business ethics that uphold the interests of all our customers
§ Ensure all interactions with customers are focused on delivering a fair outcome, including having the right products for their needs
§ Comply with any specific responsibilities necessary for your role as outlined by your line manager, the Culture & People or assurance teams (compliance, risk, internal audit) and ensure you keep up to date with developments in these areas. This may include, amongst others, Beazley’s underwriting control standards, Beazley’s claims control standards, other Beazley standards and customer relationship management
§ Carry out additional responsibilities as individually notified, either through your objectives or through the learning management system. These may include membership of any Beazley committees or working groups
Personal Specification:
Education and Qualifications
§ Degree-level educated and/or relevant professional qualifications
Skills and abilities
§ Ability to manage expectations of senior management and key stakeholders, interacting professionally and with credibility
§ Ability to build strong partnering relationships with a wide range of stakeholders
§ Excellent communicator, both verbal and written
§ Ability to challenge, negotiate with, influence and persuade both internal and external parties
§ Strong leadership and people management skills
§ Technically skilled and proficient
§ Good attention to detail with the ability to produce high quality advice
§ Ability to deal with problems in a practical and common sense way, and make sound decisions
§ Analytical, strong attention to detail, with ability to see bigger picture
Knowledge and experience
§ Strong understanding of the insurance market and framework – essential
§ In-depth regulator relations experience in an insurance-related organisation – essential
§ Experience of working in a global and fast paced business environment – essential
§ Experience of managing or working within a regulatory engagement team or equivalent – highly advantageous
§ Experience of working within the PRA – highly advantageous
§ Good understanding and experience of managing compliance with Solvency II and other PRA requirements, standards and expectations – desirable
§ Strong knowledge of property and casualty insurance – desirable
§ Proven leadership/management experience, with experience of leading/managing strategic change – desirable
§ Experience of reporting and presenting to boards and committees – desirable
§ Proficient in Microsoft 365 apps – desirable
Aptitude and Disposition
§ Energetic, enthusiastic and positive
§ Self-motivated with the ability to work autonomously
§ Highest degree of integrity/discretion
§ Work effectively under pressure, to deadlines and handling unforeseen circumstances
§ Organised, with strong prioritisation skills
§ Firm but diplomatic
§ Friendly and approachable
§ Team player
§ Flexible and pragmatic
§ Able to manage a changing environment (both internal and external)
Expected salary:
Location: United Kingdom
Job date: Wed, 01 Nov 2023 00:30:29 GMT
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]]>The post Regulatory Affairs Manager – Nutrition – UK/EMEA appeared first on World News: Entertainment, lifestyle, Health, Technology.
]]>Job description: Regulatory Affairs Manager – Nutrition – UK/EMEA
Our client is a global healthcare leader, creating breakthrough science to improve people’s health. They’re always looking towards the future, anticipating changes in medical science and technology. They have a broad portfolio of products which includes nutrition, diagnostic systems and tests, vascular devices, blood glucose monitoring systems, and veterinary care. An exciting new opportunity is available for a Regulatory Affairs Manager working within their Nutrition division, based from their Maidenhead office. Their nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. You will be responsible for developing and implementing regulatory strategy for registration and reimbursement of new institutional products and for placing on the market of out-of-pocket products. Key responsibilities include:
Required skills and experience:
As you would expect with a global market leader, they offer a fantastic range of benefits including competitive salaries, a superb defined contribution pension scheme, private healthcare, life assurance and a flexible benefits scheme. Please apply online or contact CHASE on 0131 553 6644 for further information. Reference number: 33679
Expected salary:
Location: Berkshire
Job date: Sat, 02 Dec 2023 23:49:36 GMT
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]]>The post Staff Regulatory Affairs Specialist – Hybrid appeared first on World News: Entertainment, lifestyle, Health, Technology.
]]>Job description: Job Description Summary As Staff Regulatory Affairs Specialist, you will primarily focus on maintaining continued market access within our existing product portfolio and provide regulatory support for new product development projects. This exciting position will include support of BD joint venture priorities including innovative product launches with PreAnalytiX.
Job Description
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.
Our vision for Speciman Management at BD
Specimen Management (BD SM) develops some of the most widely used products in the field of specimen collection including acquisition of the sample, collection into an appropriate container, and also emerging point-of-care applications. Our team has the unique opportunity to be involved with both medical devices and in vitro diagnostics, allowing you to broaden your expertise and grow in your career.
Key responsibilities will include:
Coordinate, prepare, and execute premarket applications to the US FDA including Premarket Notification [510(k)], Pre-Sub, IDE, PMA, and De Novo submissions in a timely manner. Act as liaison with FDA regarding product submissions.
Assess necessity for submitting a 510(k) application for proposed device modifications. Prepare robust non-filing justifications for changes that do not require a 510(k) submission.
Coordinate and prepare technical files for submission to European Notified Bodies for timely CE marking of new and modified products, with appropriate input from supporting functions (R&D, Quality, Manufacturing, Medical Affairs, etc.).
Represent RA and demonstrate leadership in complex product development teams by identifying and interpreting relevant regulatory requirements, and providing actionable regulatory guidance throughout the product development cycle prior to regulatory submission.
Identify and communicate appropriately quantified risks and mitigation approaches associated with regulatory strategies to stakeholders.
Support development and execution of global regulatory strategies by collaborating closely with international regulatory associates to register our devices worldwide.
Lead regulatory efforts required to comply with new regulations (e.g., EU MDR/IVDR, MDSAP) and other requirements including changes to international standards.
Review and approve product labeling, promotional materials, and advertising materials to ensure regulatory compliance.
Review clinical and human factors/usability protocols/reports to assure collection of appropriate data for regulatory submissions and regulatory compliance.
Engages with Medical Affairs in the development and approval of Clinical Evaluation Reports to assure the documents meet regulatory requirements.
Ensures FDA device listings and facility registrations are maintained.
Request FOI information and maintain FOI files in alignment with business strategies.
Develop and maintain standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards.
Coordinate and respond to requests for product information, and questionnaires requested by customers.
Represent BD in relevant external trade organizations and lead/participate in regulatory standards development/compliance activities as necessary to support BD’s continuous product development and compliance efforts.
Remain current on regulations affecting BD products (EU MDR/IVDR, reclassification activities, etc.) and keep the relevant team and supervisors informed about potential impact.
Identify ways to improve the efficiency of current work process and execute them.
Carry out the above tasks with limited supervision.
About you: To be successful in this role, you require:
Minimum bachelor’s degree in a technical discipline (e.g., engineering, bioengineering, biology, chemistry.) Advanced degree preferred.
Minimum 5 years Regulatory Affairs experience in medical device or vitro diagnostic device companies or 3 years of experience with an advanced degree.
Demonstrated ability to resolve problems and to make appropriate regulatory decisions under pressure.
Demonstrated success in the preparation, completion or review of regulatory submissions (PMA, 510(k), IDE) to FDA and other global regulatory agencies.
Experience in negotiating with regulatory authority personnel (e.g. FDA, Notified Bodies) in medical device and in vitro diagnostic areas preferred.
International product registration experience preferred.
Demonstrated global perspective, customer focus, cross-functional collaboration and teamwork skills.
This is a hybrid position where candidates are required to be in the office a minimum of 3 days a week. Office location is either Franklin Lakes, NJ or Sparks, MD.
**This position does not offer relocation assistance**
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
PDN
Primary Work Location USA NJ – Franklin Lakes
Additional Locations USA MD – Sparks – 26 Loveton Circle
Work Shift
Expected salary:
Location: Franklin Lakes, NJ
Job date: Thu, 16 Nov 2023 04:51:18 GMT
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Expected salary:
Location: Spring House, PA
Job date: Thu, 23 Nov 2023 23:23:58 GMT
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