Senior Regulatory Affairs Lead - MedTech Urology

BD; Covington (GA); Hybrid; USD 110,000 - 165,000; Full time

Job summary

BD is seeking a Senior Regulatory Affairs Specialist for UCC, focusing on US and CE marking submissions in a hybrid role based in Covington, GA. The right candidate will drive regulatory strategies, prepare technical documentation, and support post-market activities across global regions.

Minimum 4 years in medical device regulatory affairs, with strong knowledge of FDA requirements and EU MDR, plus excellent writing and cross-functional collaboration skills.

Qualifications

• Bachelor of Science in a scientific discipline, engineering, or other regulated field.
• Minimum 4 years of Regulatory Affairs experience in medical devices.
• Experience with US FDA regulations (21 CFR Part 820) and EU MDR/regulatory submissions.
• Experience with regulatory strategies, change assessments, and readiness for submissions.
• Strong technical writing, documentation development, and cross-functional collaboration.

Responsibilities

• Regulatory support through product lifecycle on project teams and developing regulatory strategies.
• Prepare and revise STED/Technical Files for CE marking and Notified Body interactions.
• Provide support for post-market activities including remedial actions and labeling.
• Prepare and support FDA 510(k) submissions and change assessments.
• Travel up to 15% as required.

Skills

Regulatory strategy

FDA 510(k)

EU MDR

Regulatory compliance

Project management

Technical writing

Education

Bachelor of Science in science/engineering

RAC Certification

Job description

BD is seeking a Senior Regulatory Affairs Specialist for UCC, focusing on US and CE marking submissions in a hybrid role based in Covington, GA. The right candidate will drive regulatory strategies, prepare technical documentation, and support post-market activities across global regions.

Minimum 4 years in medical device regulatory affairs, with strong knowledge of FDA requirements and EU MDR, plus excellent writing and cross-functional collaboration skills.