Job title: VP Laboratory Systems Regulatory Affairs
Company: Siemens
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:
- Serving as a key and active member Quality and Regulatory organization, interacting with the team and other business functions to ensure objectives are aligned and that the company is performing to operational objectives.
- Coaching and mentoring the Regulatory organization ensuring appropriate levels of accountability for decision making and clearly communicate cross functionally within the organization
- Providing management and leadership to the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes to gain product approvals worldwide.
- Tracking and maintaining product approvals and completes all necessary notifications, supplements, amendments, listings, and yearly reports for products on a global basis
- Providing RA support through products’ life cycles
- Providing counsel, training and interpretation and guidance on FDA, EU, China and other regulatory requirements to all company personnel.
- Overseeing preparation and filing of all regulatory documents with the FDA and international regulatory agencies.
- Developing and maintaining functional external relationships with FDA and Notified Body and other regulatory officials.
- Ensuring current and ongoing Regulatory Intelligence information is provided with analysis of impact to the business.
- Directing the development of systems, practices and processes to ensure effective ongoing review of product design and change requirements to ensure ability to launch new products into the market
- Providing leadership and direction for significant deviation events that may impact compliance status or significant business risk.
This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers
- High level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal direction.
- Excellent communications and presentation skills.
- Ability to lead, influence, create and work within cross-functional, cross geography (including remote) team environments.
- Assertive, take-charge, proven manager with a strong results orientation, positive “can do” attitude, ability to adapt to changing regulatory and business environment and a sense of urgency to get things done.
- Demonstrated success in Regulatory Affairs, including oversight or submissions for new products and product changes in IVDs and with audits.
- Technical and scientific knowledge is required to understand the products and to review scientific issues and submission documents, labelling claims and clinical data. Experience with IVD manufacturing and/or IVD research and development strongly preferred.
- Strong written and verbal communication skills; must be articulate and able to communicate effectively with corporate officers, DVPs, directors, managers, and employees across the organization.
- Very strong attention to detail.
- Strong skills in Microsoft Office, especially in Word, Excel, and PowerPoint.
- Adaptability, Innovation, Initiative, Teamwork, Quality of Work, Commitment
Required skills to have for the success of this role
- Master of Science degree required, advanced degree preferred.
- 15+ years of IVD and/or Pharmaceutical regulatory required.
- 10+ years leadership experience required.
- Experience in strategic planning and collaboration with executive and key operational groups.
- Progressive & proven record of leadership in managing regulatory organizations with global responsibility and establishing long term strategic growth initiatives.
- Experience with all phases of the product development lifecycle, including concept, design, implementation, verification and validation activities necessary for product commercialization.
- Extensive experience in cGMP and other Regulatory compliance requirements. Experienced in regulatory filings for US (510(k), IDE and PMA), EU, China and other key countries/regions.
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.
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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.
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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.
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Expected salary:
Location: Tarrytown, NY
Job date: Wed, 25 Oct 2023 23:54:03 GMT
