The Regulatory Affairs Manager will lead and manage regulatory submissions, approvals, and compliance activities for medical devices ensuring timely market access and post-market compliance
Job Summary
The Regulatory Affairs Manager will lead and manage regulatory submissions, approvals, and compliance activities for medical devices ensuring timely market access and post-market compliance.
BD values an environment that supports learning, growth, and collaboration to foster creativity and innovation in a fast-paced healthcare industry.
BD is an Equal Opportunity Employer that encourages bringing your authentic self to work and offers a culture where employees can learn, grow, and thrive.
Matching Summary
The Regulatory Affairs Manager will lead and manage regulatory submissions, approvals, and compliance activities for medical devices ensuring timely market access and post-market compliance.
Skills & Requirements
Must-have
Regulatory submissions and approvals
Medical device regulatory compliance
Global regulatory requirements knowledge
Quality management systems expertise
Cross-functional regulatory support
On-site work in Covington, GA
Nice-to-have
Strong analytical and problem-solving skills
Excellent written and verbal communication
Ability to work independently and collaboratively
Regulatory Affairs Certification (RAC)
Proficiency in Microsoft Office and submission software
Key Requirements
Bachelor's degree in scientific or engineering field
5-7 years Regulatory Affairs experience in medical devices
Ability to work on-site in Covington, GA
Experience with FDA 510(k), PMA, CE Mark submissions