Senior Regulatory Affairs Specialist - Medical Devices- FDA focus

As a Senior Regulatory Affairs Specialist – FDA, you will lead FDA submission activities, serve as the primary liaison with regulatory authorities, and partner with cross-functional teams to ensure our products meet the highest standards of safety and effectiveness.

Requirements

• 5+ years of related experience
• Bachelor's degree
• Advanced training ‘Manager Regulatory Affairs for Medical Devices’
• Experience preparing and managing FDA submissions such as 510 (k) and ideally, PMA applications