Hybrid Senior Regulatory Affairs Lead – MedTech

BD; Covington (GA); Hybrid; USD 105,000 - 150,000; Full time

Benefits offered by this job

On-site collaboration

Job summary

BD is seeking a Senior Regulatory Affairs Specialist in the U.S. for Urology and Critical Care. You will lead regulatory submissions, develop strategies, and support lifecycle activities across geographies. On-site in Covington, with flexible remote Fridays, and up to 15% travel.

Ideal candidates have a BS in a scientific field and 4+ years of medical device regulatory experience, including FDA 510(k) and EU MDR, with strong technical writing and project management skills.

Qualifications

• BS degree in a scientific discipline, engineering, or regulated field.
• 4+ years of Regulatory Affairs experience in medical devices.
• Experience with FDA 510(k) and EU MDR regulatory activities.
• Knowledge of 21 CFR Part 820 and global registrations.

Responsibilities

• Provide regulatory submissions for US and CE marking.
• Develop regulatory strategies and maintain timelines.
• Prepare and maintain technical documentation (STED/records).
• Support post-market activities and change controls.
• Interact with regulatory authorities and notified bodies.

Skills

Regulatory strategy

Technical writing

Cross-functional teamwork

Project management

Communication

Independent work

Education

Bachelor of Science (BS) degree

Job description

BD is seeking a Senior Regulatory Affairs Specialist in the U.S. for Urology and Critical Care. You will lead regulatory submissions, develop strategies, and support lifecycle activities across geographies. On-site in Covington, with flexible remote Fridays, and up to 15% travel.

Ideal candidates have a BS in a scientific field and 4+ years of medical device regulatory experience, including FDA 510(k) and EU MDR, with strong technical writing and project management skills.