Manager, Regulatory Affairs

Company Overview

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. The role involves participating in cross‑functional teams, leading the development of global regulatory strategies, authoring regulatory submissions, leading interactions with regulatory agencies/notified bodies, reviewing design control documents and product labeling, and evaluating proposed device changes.

The manager will interpret and communicate regulatory issues to ensure the business is aware of opportunities, risks, and concerns, and provide recommendations to minimize risk.

• Coordinate RA activities for direct reports
• Manage RA responsibilities and functional goals, including FDA and BD required filings and new information dissemination
• Make preliminary determinations regarding the appropriate US and/or international regulatory submission requirements for new or modified products
• Review and approve documentation for change requests, labeling artwork changes, recall and FDA inspection assistance, as defined by BD procedures
• Facilitate FDA submission activities and create 510(k) rationales, global submissions, and/or rationales
• Write new product submissions, prepare and/or contribute to FDA and required BD reports, and ensure RA department support on new product teams
• Keep knowledge of FDA and/or global requirements current by attending industry, FDA, and corporate seminars, when possible
• Act as alternate liaison for quality system audits and inspections
• Develop global regulatory strategies
• Supervise maintenance of US, CE, and international documentation
• Coordinate and manage EU MDR technical file audits and support other external and internal audits

• Bachelor’s degree in a scientific field
• 6–8 years of 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
• Proficiency 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+ year of management experience
• Regulatory Affairs Professional Society (RAPS) certification
• Comprehensive understanding of global medical device regulations, with in‑depth knowledge of US and EU requirements

Primary

Work Location:

USA, Utah – Salt Lake City, BAS. For most roles, BD requires 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 indicated in the job posting.

For certain roles, employment is contingent upon the company’s receipt of sufficient proof 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.

At BD, we prioritize on‑site collaboration to foster creativity, innovation, and effective problem‑solving, while also offering flexibility. A career at BD means being part of a team that values your opinions and contributions, encourages authenticity, and emphasizes accountability, continuous improvement, and growth.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.