Senior Regulatory Affairs Manager - MedTech (Onsite)

bdx; Covington (GA); On-site; USD 120,000 - 180,000; Full time

Job summary

BD in Covington, GA is seeking a senior Regulatory Affairs leader to shape regulatory strategies for medical devices across development and post-market stages.

You will prepare submissions (510(k), PMA, CE), interact with regulators, mentor teams, and ensure compliance with global standards.

This onsite role emphasizes collaboration with R&D, Quality, Clinical, and Marketing to drive BD's health tech portfolio.

Qualifications

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

Responsibilities

• Develop and implement regulatory strategies for new product development and lifecycle management.
• Prepare and submit regulatory documents to global health authorities.
• Serve as primary regulatory contact for projects during submissions, reviews, inspections.
• Interpret regulations and ensure compliance throughout development to commercialization.
• Lead and mentor junior regulatory affairs professionals.
• Participate in audits and provide regulatory expertise.
• Assess regulatory impact of product, manufacturing, and quality system changes.
• Collaborate with R&D, Quality, Clinical, Marketing to achieve regulatory objectives.
• Monitor regulatory changes and industry trends relevant to BD portfolio.

Skills

Regulatory strategy

Leadership experience

FDA regulations

ISO 13485

Regulatory submissions

Communication skills

Project leadership

RAC certification

Regulatory information management

Education

Bachelor's degree in a scientific or technical discipline

MS or PhD preferred

Tools

Regulatory information management systems

Job description

BD in Covington, GA is seeking a senior Regulatory Affairs leader to shape regulatory strategies for medical devices across development and post-market stages.

You will prepare submissions (510(k), PMA, CE), interact with regulators, mentor teams, and ensure compliance with global standards.

This onsite role emphasizes collaboration with R&D, Quality, Clinical, and Marketing to drive BD's health tech portfolio.