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.
JOB DESCRIPTION:
1. Represent Regulatory Affairs on product development teams to support new product development and change control, ensuring compliance with US, EU, and other global regulatory requirements.
2. Author FDA submissions (e.g., 510(k), Q-Sub), EU technical documentation under MDR, and other global regulatory filings.
3. Evaluate medical device regulations and lead the development of global regulatory strategies to bring products to market.
4. Review and approve design control documentation in consideration of US, EU, and other global regulatory requirements.
5. Review and approve product labeling, promotional materials, and advertising materials to ensure regulatory compliance.
6. Serve as a point of contact for FDA, EU Notified Bodies, and other regulatory agencies regarding submissions and related issues.
7. Independently assess product changes for regulatory impact, including US and CE Mark implications, and prepare resulting notifications or non-filing justifications.
8. Communicate regulatory changes to global regions and support preparation of global notifications as needed.
9. Stay informed of new and evolving global regulatory requirements and communicate relevant updates to project teams.
10. Identify and communicate appropriately quantified risks and mitigation strategies associated with regulatory strategies to collaborators.
11. Lead regulatory efforts required to align with new regulations and standards (e.g., EU MDR, IVDR, MDSAP).
12. Write and update standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards.
13. Demonstrate working knowledge of regulations for sterile Class II devices, preferably related to IV infusion disposables.
14. Draft and deliver RA-related training for the RA group and/or cross-functional business collaborators (e.g., Marketing, Medical Affairs, R&D).
15. Identify current work process inefficiencies and implement improvements.
16. Execute the above tasks with limited supervision.
Minimum Qualifications:
17. Bachelor’s degree in a scientific, health sciences, or technical discipline (e.g., Regulatory Affairs, Quality Assurance, Engineering, Bioengineering, Biology, Chemistry).
18. Minimum of 5 years of Regulatory Affairs experience in medical devices, preferably sterile single-use disposable products.
Preferred Qualifications
19. Advanced degree (MS, PhD, or RAC certification).
20. Demonstrated success in the preparation and completion of regulatory submissions (Q-Sub, PMA, IDE) to FDA and other global regulatory agencies.
21. Experience negotiating with regulatory authority personnel (e.g., FDA, Notified Bodies).
22. Familiarity with STED format and technical file updates for CE marking under EU MDR.
23. Experience supporting regulatory strategy throughout the product lifecycle.
24. Hands-on experience with EU regulatory submissions, including preparation and maintenance of technical documentation under EU MDR.
25. Demonstrated success in the preparation and completion of multiple 510(k) submissions.
26. Experience working with FDA personnel during 510(k) review and meetings with the Agency.
27. Proven ability to resolve problems and make appropriate regulatory decisions.
28. Experience supporting development and execution of global regulatory strategies in collaboration with international RA teams.
Knowledge, Skills, and Abilities:
29. Ability to develop regulatory strategies for Change Controls (CC) and establish regulatory requirements.
30. Strong cross-functional collaboration and influencing skills.
31. Current knowledge of U.S. and European medical device regulations.
32. Strong technical writing skills and ability to compile successful submissions for the appropriate audience.
33. Ability to maintain confidentiality in handling regulatory and clinical documentation.
34. Strong prioritization, multitasking, and independent work skills.
35. Strong critical thinking, communication, and project management skills.
36. Ability to function effectively in a matrix organization.
37. Ability to mentor and teach other regulatory associates.
38. Proven experience owning and managing the end-to-end process of authoring, submitting, and obtaining regulatory approvals/clearances (e.g., 510(k)s), including responding to agency deficiencies.
39. Proficient in Microsoft Office tools (Word, Excel, PowerPoint) and Adobe.
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
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.