Senior Regulatory Affairs Specialist - Medical Devices- Fda Focus
Novanta
Sarasota, FL, United States
Fda submissions
510(k) applications
Regulatory strategy
This role is responsible for developing and executing FDA submission plans, including 510(k) applications, and serving as the primary liaison with regulatory authorities
Job Summary
This role is responsible for developing and executing FDA submission plans, including 510(k) applications, and serving as the primary liaison with regulatory authorities.
The specialist ensures adherence to design control and change management processes, supports audits and customer interactions, and manages safety-related complaints in collaboration with Medical Affairs.
Novanta is committed to fostering a culture that embraces teamwork, collaboration, and empowerment, creating a great place to work powered by innovations that matter.
Matching Summary
This role is responsible for developing and executing FDA submission plans, including 510(k) applications, and serving as the primary liaison with regulatory authorities.
Skills & Requirements
Must-have
FDA submissions
510(k) applications
regulatory strategy
Quality Management System
design control processes
Nice-to-have
teamwork and collaboration
cross-functional partnerships
continuous innovation
Key Requirements
5+ years of related experience
Bachelor's degree
Advanced training "Manager Regulatory Affairs for Medical Devices"