Regulatory Affairs Manager

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.

The human element, across our global teams, enables 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.

The Regulatory Affairs Manager will lead and manage regulatory submissions, approvals, and compliance activities for medical devices. This role ensures that products meet all national and international regulatory requirements, facilitating timely market access and maintaining post-market compliance.

• Develop and execute regulatory strategies for new product introductions and product lifecycle management.
• Prepare, review, and submit regulatory filings (e.g., 510(k), PMA, CE Mark, etc.) to regulatory agencies worldwide.
• Act as the primary liaison with regulatory agencies during pre-submission meetings, reviews, and inspections.
• Interpret and apply complex regulatory requirements to product development, manufacturing, and marketing activities.
• Conduct regulatory assessments for design changes, manufacturing changes, and labeling updates to determine impact and required submissions.
• Manage and maintain regulatory licenses, registrations, and approvals.
• Provide regulatory guidance and support to cross-functional teams, including R&D, Quality, Marketing, and Clinical Affairs.
• Monitor and analyze evolving global regulatory landscapes, assessing potential impacts on products and processes.
• Participate in internal and external audits to ensure compliance with quality system regulations (e.g., ISO 13485, 21 CFR Part 820).
• Develop and deliver regulatory training to internal stakeholders.

• Bachelor's degree in a scientific, engineering, or related field; advanced degree (Master's or Ph.D.) preferred.
• Minimum of 5-7 years of experience in Regulatory Affairs within the medical device industry.

• Demonstrated success in preparing and obtaining regulatory approvals (e.g., FDA 510(k), PMA, CE Mark).
• In-depth knowledge of global medical device regulations (e.g., FDA regulations, MDD/MDR, Health Canada, TGA, MHLW).
• Strong understanding of quality management systems (e.g., ISO 13485, 21 CFR Part 820).
• Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory information.
• Strong analytical and problem-solving abilities, with keen attention to detail.
• Ability to work independently and collaboratively in a fast-paced, dynamic environment.
• RAC (Regulatory Affairs Certification) preferred.
• Proficiency in Microsoft Office Suite and regulatory submission software.

BD prioritizes on-site collaboration to foster creativity, innovation, and effective problem-solving in the fast-paced healthcare industry. For most roles, a minimum of 4 days of in-office presence per week is expected 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.

Employment may be contingent upon proof of full vaccination against COVID-19 where required by location. 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.

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,…