Senior Manager Regulatory Affairs

Lead Regulatory Strategy for Innovative Medical Devices

We’re seeking an experienced Senior Manager, Regulatory Affairs to lead regulatory strategy and execution across new product development, product lifecycle management, and post-market activities within a leading medical-device organization.

This is a high-impact opportunity for a regulatory affairs leader who can combine deep FDA/international regulatory expertise with strong cross-functional leadership and help guide products from development through commercialization.

• Develop and execute comprehensive regulatory strategies for new products and product lifecycle activities
• Lead regulatory planning for product development, commercialization, and post-market surveillance
• Prepare, review, and submit regulatory applications including 510(k) s, PMAs, Dossiers, Technical Files, and international submissions
• Serve as the primary regulatory contact for assigned programs
• Communicate directly with FDA and international regulatory authorities throughout submissions, reviews, and inspections
• Interpret complex regulations, guidance, and industry standards and translate them into practical business strategies
• Assess regulatory implications of product, manufacturing, and quality-system changes
• Lead and mentor Regulatory Affairs professionals while building a culture of compliance and continuous improvement
• Support internal and external audits with regulatory expertise
• Partner closely with R&D, Quality, Clinical, Marketing, Manufacturing, and other cross-functional teams
• Monitor emerging regulatory requirements and industry trends and communicate their impact to the organization
• Manage multiple high-priority projects in a fast-paced environment

• Bachelor’s degree in a scientific or technical discipline such as Biomedical Engineering, Chemistry, Biology, or related field
• 8-10+ years of Regulatory Affairs experience within the medical-device industry
• 3-5+ years in a senior or leadership capacity
• Demonstrated experience preparing and submitting regulatory applications such as:
• 510(k)
• PMA
• CE Mark / EU MDR
• International registrations
• Strong knowledge of:
• FDA regulations / 21 CFR
• ISO 13485
• EU Medical Device Regulation (MDR)
• International medical-device regulations
• Strong project management and organizational skills
• Ability to communicate complex regulatory concepts to technical and non-technical stakeholders
• Experience with regulatory information management systems and tools
• MS or PhD in a relevant technical/scientific discipline
• RAC certification
• Experience leading and developing Regulatory Affairs teams
• Broad international regulatory experience

This isn't a role where you'll simply maintain regulatory documentation.

You'll have the opportunity to shape regulatory strategy
, influence product development decisions, work directly with regulatory authorities, and partner with R&D, Quality, Clinical, and commercial leaders.

It's an ideal opportunity for a Senior Regulatory Affairs professional ready to take greater ownership and leadership responsibility within a sophisticated medical-device environment.

Covington, Georgia

The role is primarily on-site, with work-from-home Fridays
, providing a consistent hybrid schedule while maintaining the collaboration and visibility needed for a highly cross-functional regulatory organization.