Senior Regulatory Affairs Specialist - MedDev (US/EU MDR)

BD; United States; Hybrid; USD 110,000 - 160,000; Full time

Job summary

BD is seeking a Senior Regulatory Affairs Specialist in the United States to lead regulatory submissions and strategy for U.S. and CE marking. The role focuses on U.S.

FDA and EU MDR compliance, with on-site work four days weekly in Covington and remote Fridays, and limited travel. You will develop regulatory strategies, manage change controls, and prepare STED/Technical Files while collaborating with internal teams and external regulators.

Qualifications

• Minimum 4 years of Regulatory Affairs experience within the medical device industry.
• Bachelor of Science degree required, preferably in a scientific discipline or engineering.
• Working knowledge of U.S. FDA regulations (21 CFR Part 820) and EU MDR.
• Experience with regulatory registrations (FDA, EU) and post-market activities.
• Strong technical writing and cross-functional teamwork skills.

Responsibilities

• Provide regulatory support across product lifecycle and project teams.
• Prepare/revise STED/Technical File for CE marking and Notified Body interactions.
• Support post-market actions including labeling and corrective actions.
• Prepare FDA 510(k) submissions and change assessments as needed.
• Travel up to 15% as required.

Skills

Regulatory affairs

FDA regulations

EU MDR

Technical writing

Cross-functional collaboration

Project management

Education

Bachelor of Science

Tools

Regulatory submissions software

Job description

BD is seeking a Senior Regulatory Affairs Specialist in the United States to lead regulatory submissions and strategy for U.S. and CE marking. The role focuses on U.S.

FDA and EU MDR compliance, with on-site work four days weekly in Covington and remote Fridays, and limited travel. You will develop regulatory strategies, manage change controls, and prepare STED/Technical Files while collaborating with internal teams and external regulators.