Senior Regulatory Affairs Leader - MedTech, Onsite Covington

BD; Covington (GA); On-site; USD 130,000 - 160,000; Full time

Job summary

BD in Covington, Georgia is seeking an experienced Senior Regulatory Affairs professional to lead regulatory strategies across the full product lifecycle, ensuring compliance and timely approvals. This role emphasizes cross-functional collaboration with R&D, Quality, and Marketing to align regulatory plans with business objectives.

You will prepare and submit regulatory documents (510(k), PMA, CE Mark), interact with global health authorities, and mentor junior staff.

Qualifications

• Bachelor's degree in a scientific or technical discipline; MS/PhD preferred.
• 8–10 years in Regulatory Affairs in medical devices, 3–5 years in leadership roles.
• Experience preparing/submitting 510(k), PMA, CE Mark and international registrations.
• Strong knowledge of FDA (21 CFR Parts 800s), ISO 13485, EU MDR and other regs.
• Excellent written and verbal communication; ability to lead projects in a fast-paced environment.

Responsibilities

• Develop and implement regulatory strategies for new product development and lifecycle management.
• Prepare, review, and submit regulatory documents (510(k), PMA, CE, etc.).
• Serve as primary regulatory contact with agencies during submissions, reviews, and inspections.
• Mentor junior regulatory staff and drive a culture of compliance and continuous improvement.
• Collaborate with R&D, Quality, Clinical, Marketing and other departments to meet regulatory objectives.
• Monitor new or changing regulatory requirements and industry trends.

Skills

Regulatory leadership

Regulatory affairs

FDA regulations

ISO 13485

Project leadership

Education

Bachelor's degree in science/engineering

MS/PhD preferred

Tools

Regulatory information management systems

Job description

BD in Covington, Georgia is seeking an experienced Senior Regulatory Affairs professional to lead regulatory strategies across the full product lifecycle, ensuring compliance and timely approvals. This role emphasizes cross-functional collaboration with R&D, Quality, and Marketing to align regulatory plans with business objectives.

You will prepare and submit regulatory documents (510(k), PMA, CE Mark), interact with global health authorities, and mentor junior staff.