Job title: Senior Regulatory Affairs Specialist – Hybrid
Company: BD
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
