Senior Regulatory Affairs Lead – MedTech (US/EU)

Regulatory Jobs; Covington (GA); Hybrid; USD 90,000 - 130,000; Full time

Job summary

BD in Covington, GA seeks a Senior Regulatory Affairs Specialist to lead US and CE submissions and drive regulatory strategies across regions. The role involves preparing STED/Technical Files, supporting MDR maintenance, and guiding regulatory deliverables with cross-functional teams.

You will collaborate with internal stakeholders and external bodies, manage change assessments, and ensure compliance across the product lifecycle, with up to 15% travel.

Qualifications

• Bachelor of Science (BS) degree required in a scientific discipline, engineering, or other regulated field.
• Minimum 4 years regulatory affairs experience in medical devices.
• Experience supporting product registration, regulatory compliance, and quality system activities.

Responsibilities

• Regulatory support through the product life cycle on product project teams, including regulatory strategies and change control.
• Prepare/revise STED/Technical Files for CE marking and Notified Bodies.
• Support post-market activities including remediation actions and labeling.
• Prepare and support FDA 510(k) submissions and change assessments.
• Travel up to 15%. Little travel required.

Skills

Regulatory Affairs

Regulatory strategy

Technical writing

Cross-functional collaboration

Regulatory submissions

Project management

Education

BS degree in a scientific field

Job description

BD in Covington, GA seeks a Senior Regulatory Affairs Specialist to lead US and CE submissions and drive regulatory strategies across regions. The role involves preparing STED/Technical Files, supporting MDR maintenance, and guiding regulatory deliverables with cross-functional teams.

You will collaborate with internal stakeholders and external bodies, manage change assessments, and ensure compliance across the product lifecycle, with up to 15% travel.