Senior Regulatory Affairs Specialist – Hybrid (U.S./EU MDR)

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

Job summary

BD, a leading medical technology company, seeks a Senior Regulatory Affairs Specialist to drive regulatory strategies and submissions across US/EU regions. You will develop regulatory plans, maintain technical documentation, and liaise with authorities to ensure compliance throughout the product lifecycle.

The role requires a BS in a scientific field, 4+ years in medical devices, and strong technical writing.

Qualifications

• BS degree in a scientific discipline, engineering, or other regulated field.
• Minimum 4 years of Regulatory Affairs experience within the medical device industry.
• Experience supporting product registration, regulatory compliance, and quality system activities for medical devices.
• Working knowledge of U.S. FDA regulations (21 CFR Part 820) and EU MDR.
• Experience with US, EU, and international product registrations.
• Strong technical writing skills for regulatory submissions.
• Ability to work independently and manage multiple regulatory deliverables.
• Willingness to travel up to 15%.

Responsibilities

• Regulatory support throughout the product lifecycle on project teams, including strategy development and change control.
• Prepare and revise STED technical files for CE marking and Notified Body interactions.
• Support post-market activities including remedial actions and labeling.
• Prepare and support FDA 510(k) premarket notifications and change assessments.
• Collaborate with internal customers and external auditors; manage timelines.

Skills

Regulatory affairs

Regulatory strategy

Regulatory submissions

Technical writing

Cross-functional collaboration

Project management

Education

Bachelor of Science in a scientific field

RAC certification (preferred)

Tools

FDA regulations knowledge

EU MDR knowledge

510(k) submissions

Notified Bodies interaction

Job description

BD, a leading medical technology company, seeks a Senior Regulatory Affairs Specialist to drive regulatory strategies and submissions across US/EU regions. You will develop regulatory plans, maintain technical documentation, and liaise with authorities to ensure compliance throughout the product lifecycle.

The role requires a BS in a scientific field, 4+ years in medical devices, and strong technical writing.