Senior RA Specialist

Job Description Summary

The Senior Regulatory Affairs (RA) Specialist will represent Regulatory Affairs within the Worldwide Infusion Preparation and Delivery (WWIPD) platform of the Medication Delivery Solutions business unit at Becton Dickinson (BD). This role supports compliance projects, product engineering, new product development, and other regulatory‑related initiatives and maintenance activities.

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 Med Tech 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.

• 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.
• Author FDA submissions (e.g., 510(k), Q-Sub), EU technical documentation under MDR, and other global regulatory filings.
• Evaluate medical device regulations and lead the development of global regulatory strategies to bring products to market.
• Review and approve design control documentation in consideration of US, EU, and other global regulatory requirements.
• Review and approve product labeling, promotional materials, and advertising materials to ensure regulatory compliance.
• Serve as a point of contact for FDA, EU Notified Bodies, and other regulatory agencies regarding submissions and related issues.
• Independently assess product changes for regulatory impact, including US and CE Mark implications, and prepare resulting notifications or non‑filing justifications.
• Communicate regulatory changes to global regions and support preparation of global notifications as needed.
• Stay informed of new and evolving global regulatory requirements and communicate relevant updates to project teams.
• Identify and communicate appropriately quantified risks and mitigation strategies associated with regulatory strategies to collaborators.
• Lead regulatory efforts required to align with new regulations and standards (e.g., EU MDR, IVDR, MDSAP).
• Write and update standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards.
• Demonstrate working knowledge of regulations for sterile Class II devices, preferably related to IV infusion disposables.
• Draft and deliver RA‑related training for the RA group and/or cross‑functional business collaborators (e.g., Marketing, Medical Affairs, R&D).
• Identify current work process inefficiencies and implement improvements.
• Execute the above tasks with limited supervision.

• Bachelor’s degree in a scientific, health sciences, or technical discipline (e.g., Regulatory Affairs, Quality Assurance, Engineering, Bioengineering, Biology, Chemistry).
• Minimum of 5 years of Regulatory Affairs experience in medical devices, preferably sterile single‑use disposable products.

• Advanced degree (MS, PhD, or RAC certification).
• Demonstrated success in the preparation and completion of regulatory submissions (Q-Sub, PMA, IDE) to FDA and other global regulatory agencies.
• Experience negotiating with regulatory authority personnel (e.g., FDA, Notified Bodies).
• Familiarity with STED format and technical file updates for CE marking under EU MDR.
• Experience supporting regulatory strategy throughout the product lifecycle.
• Hands‑on experience with EU regulatory submissions, including preparation and maintenance of technical documentation under EU MDR.
• Demonstrated success in the preparation and completion of multiple 510(k) submissions.
• Experience working with FDA personnel during 510(k) review and meetings with the Agency.
• Proven ability to resolve problems and make…