Senior Regulatory Affairs Specialist — MedTech (Hybrid)

Becton Dickinson; Covington (GA); Hybrid; USD 110,000 - 150,000; Full time

Job summary

BD (Becton, Dickinson and Company) is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions and maintain compliance for medical devices. The role supports U.S. and CE marking activities and helps manage regulatory processes across regions.

The position offers on-site work four days per week in Covington, GA, with remote Fridays, and requires up to 15% travel. Collaboration with cross-functional teams is essential to ensure timely submissions and regulatory compliance.

Qualifications

• BS degree in a science, engineering, or regulated field.
• Minimum 4 years of regulatory affairs experience in the medical device industry.
• Experience with FDA 510(k) premarket notifications and EU MDR submissions.

Responsibilities

• Regulatory support through the product lifecycle on project teams, including regulatory strategies, change control, and timelines.
• Prepare and revise STED technical files for CE marking and notified body interactions.
• Support post-market activities including labeling and remedial actions; light travel (~15%).
• Prepare and support FDA 510(k) submissions and change assessments.

Skills

Regulatory strategy development

Regulatory submissions

Project management

Technical writing

Cross-functional teamwork

Education

Bachelor of Science (BS) degree

Job description

BD (Becton, Dickinson and Company) is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions and maintain compliance for medical devices. The role supports U.S. and CE marking activities and helps manage regulatory processes across regions.

The position offers on-site work four days per week in Covington, GA, with remote Fridays, and requires up to 15% travel. Collaboration with cross-functional teams is essential to ensure timely submissions and regulatory compliance.