Senior Regulatory Affairs Specialist - Med Devices (Hybrid)

Regulatory Jobs; Covington (GA); Hybrid; USD 110,000 - 140,000; Full time

Job summary

BD is seeking a Senior Regulatory Affairs Specialist to lead US and CE marking submissions and support global registrations within UCC. The role combines independent work on regulatory strategy, documentation, and cross-functional collaboration in a fast-paced medical device environment.

The position is based on-site in Covington, GA four days a week with Friday remote, requiring up to 15% travel and strong technical writing and project management skills.

Qualifications

• Bachelor of Science degree in a scientific discipline or engineering.
• 4+ years regulatory affairs experience in the medical device industry.
• Experience with US FDA regulations and EU MDR.

Responsibilities

• Regulatory strategy development and lifecycle support.
• Prepare and revise CE/510(k) submissions.
• Support post-market activities and labeling.
• Manage change assessments and regulatory deliverables.
• Travel up to 15%.

Skills

Regulatory affairs

Technical writing

Cross-functional collaboration

Project management

FDA regulations

Communication skills

Education

BS degree in science/engineering

Job description

BD is seeking a Senior Regulatory Affairs Specialist to lead US and CE marking submissions and support global registrations within UCC. The role combines independent work on regulatory strategy, documentation, and cross-functional collaboration in a fast-paced medical device environment.

The position is based on-site in Covington, GA four days a week with Friday remote, requiring up to 15% travel and strong technical writing and project management skills.