Manager, Regulatory Affairs

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 Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

This position is responsible for implementing BD's regulatory policies and procedures related to multiple projects within the business unit. The Regulatory Affairs Manager will manage other Regulatory associates and directly support projects to bring new and modified medical devices to market and ensure ongoing compliance. You and your direct reports will participate in cross‑functional teams, lead the development of global regulatory strategies, author regulatory submissions, lead interactions with regulatory agencies/notified bodies, review design control documents and product labeling, and evaluate proposed device changes.

This role interprets and communicates regulatory issues to ensure the business is aware of opportunities, risks, and concerns, and provides recommendations to minimize risk. The ideal candidate will have excellent organizational, problem‑solving and analytical skills; manage multiple tasks and meet timeline commitments; have strong written and verbal communication skills; collaborate across cultures; interact with technical and legal associates; negotiate with regulators;

work in a team‑oriented, fast‑paced environment; and develop, mentor, and coach regulatory team members.

• Coordinates RA activities for direct reports
• Manages RA responsibilities and functional goals which may consist of FDA and BD required filings and new information dissemination
• Makes preliminary determinations regarding the appropriate US and/or International regulatory submission requirements for new or modified products
• Reviews and approves documentation Change Requests, labeling artwork changes, recall and FDA inspection assistance, as defined by BD procedures
• Facilitates FDA submission activities and creates 510(k) rationales, global submissions and/or rationales
• Writes new product submissions, prepares and/or contributes to FDA and required BD reports, and ensures RA department support on new product teams
• Keeps knowledge of FDA and/or global requirements current by attending industry, FDA, and corporate seminars, when possible
• Acts as alternate liaison for quality system audits and inspections
• Will develop global regulatory strategies
• Supervises maintenance of US, CE, and international documentation
• Involved with the coordination and management of EU MDR technical file audits; and supports other external and internal audits

• Bachelor's degree in a scientific field
• 6-8 years’ Regulatory Affairs experience in the medical device industry
• Experience leading communications with FDA, EU notified bodies, and other regulatory agencies
• Experience with US 510(k), CE mark (EU MDD/MDR), and other international requirements and submissions
• Experience with product development processes and design controls
• Proficient with Microsoft Office tools (including Word, Excel, PowerPoint)
• Knowledge of product development and medical device quality system regulations

• Master's degree in Regulatory Affairs
• 1+ years’ management experience
• Regulatory Affairs Professional Society (RAPS) certification
• Comprehensive understanding of global medical device regulations, with in-depth knowledge of US and EU requirements

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…