Senior Regulatory Affairs Specialist

About the role

We Are The People Who Give Possibilities Purpose. BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and 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. At BD, we offer an outstanding chance for a Senior Regulatory Affairs Specialist to join a world‑class team preparing regulatory submissions vital for marketing medical devices internationally. This role ensures that product development processes fulfill all regulatory demands and business objectives. You will play a key part in crafting the future of medical technology. The Sr. Regulatory Affairs Specialist independently supports projects to introduce new and updated medical devices to the market while ensuring ongoing compliance, joins cross‑functional teams, leads the creation of global regulatory strategies, writes regulatory submissions, engages with regulatory agencies and notified bodies, reviews product development documents and labeling, and assesses proposed device modifications. The Sr. Regulatory Affairs Specialist interprets and communicates regulatory issues to keep the business informed of opportunities, risks, and concerns, offering recommendations to reduce risk. This role is working onsite hybrid, 4 days a week in Salt Lake City.

Responsibilities

• Provide support for FDA Premarket Notification [510(k)] submissions and/or other FDA documentation formats in a timely manner.
• Prepare technical files for CE marking with appropriate input from various functions (R&D, Quality, Manufacturing, etc.) promptly.
• Submit notifications about significant changes to registered products to numerous geographies, including 'non-filing' justifications to EU Notified Body.
• Interact with reviewers from health agencies to respond to additional information requests during submissions.
• Review and authorize labeling to ensure Regulatory compliance.
• Assist in developing and updating clinical evaluation reports to ensure the gathering of suitable data for Regulatory submissions and adherence.
• Represent Regulatory Affairs in worldwide product life cycle development teams by reviewing, approving, and completing requirements of change control projects.
• Coordinate and collect specific registration information with R&D, Manufacturing, QA, Medical, and other applicable departments.
• Provide Regulatory mentorship throughout the product development cycle and coordinate team input.
• Submit product listings to the FDA.
• Support international registrations related to product changes, new product launches, and/or product renewals.

Requirements

• A Bachelor's degree, preferably in engineering, bioengineering, biology, chemistry, or health science.
• At least 3 years of regulatory experience in the medical device industry.
• Familiarity with a variety of medical device standards and regulations, including FDA, EU MDR 2017/745, ISO 13485.
• Proven record of guiding products through FDA, EU Notified Bodies, and/or other worldwide governing health authorities.
• Practical understanding of 510(k), MDR 2017/745, and other global regulations.

Qualifications

• Experience with vascular access devices.
• RAC – Regulatory Affairs Certification.
• Experience with Regulatory Information Management Systems (RIMS).

Skills

• Proficient in using Microsoft Office.
• Strong communication and project management skills.
• Must be able to balance multiple tasks with minimal managerial oversight.
• Attention to detail.
• Ability to learn and grasp oftentimes complex concepts quickly.