Senior Regulatory Affairs Manager — MedTech Leader

Becton Dickinson NA; Covington (GA); On-site; USD 120,000 - 180,000; Full time

Job summary

BD, a leading medical technology company, is hiring for a senior Regulatory Affairs role onsite in Covington, GA. The candidate will lead regulatory strategies, submissions, and interactions with global health authorities, guiding projects from development through commercialization.

Requirements include a scientific/technical degree with 8–10 years in Regulatory Affairs in medical devices, plus 3–5 years in leadership. Strong FDA/ISO knowledge and RAC preferred.

Qualifications

• Bachelor's degree in a scientific or technical discipline; MS/PhD preferred.
• Demonstrated expertise in preparing/submitting 510(k), PMA, CE Mark, and international registrations.
• Strong knowledge of FDA regulations (21 CFR Parts 800s), ISO 13485, EU MDR.

Responsibilities

• Develop and implement regulatory strategies for product development and lifecycle.
• Prepare, review, and submit regulatory documents (510(k), PMA, CE, international filings).
• Act as primary regulatory contact with agencies during submissions, reviews, and inspections.
• Interpret applicable regulations and standards to ensure compliance throughout development and commercialization.
• Lead and mentor junior regulatory affairs professionals toward compliance excellence.
• Participate in audits and provide regulatory expertise and support.
• Assess regulatory impact of product, manufacturing, and quality system changes.
• Collaborate with R&D, Quality, Clinical, Marketing and other departments to meet regulatory goals.
• Monitor and disseminate changes in regulatory requirements and industry trends.

Skills

Regulatory leadership

Regulatory submissions

Communication

Project management

RAC preferred

Education

Bachelor's degree in science/engineering

MS/PhD preferred

Job description

BD, a leading medical technology company, is hiring for a senior Regulatory Affairs role onsite in Covington, GA. The candidate will lead regulatory strategies, submissions, and interactions with global health authorities, guiding projects from development through commercialization.

Requirements include a scientific/technical degree with 8–10 years in Regulatory Affairs in medical devices, plus 3–5 years in leadership. Strong FDA/ISO knowledge and RAC preferred.