Senior Regulatory Affairs Specialist

Develop regulatory submissions for domestic and international spinal product clearances. Support our spinal product design teams concerning change control and spinal product regulatory submissions. Duties include:

1. Provide expertise on domestic and OUS regulatory strategies for products, including spinal devices, medical software (SaMD), medical devices containing software, radiation emitting devices, and cybersecurity;
2. Support design control activities for spinal devices, medical software (SaMD), medical devices containing software, and radiation emitting devices;
3. Apply IEC 62304 requirements during the development and improvement of the software lifecycle process for domestic and OUS submissions;
4. Prepare regulatory submissions, including 510(k) premarket notifications for the FDA;
5. Maintain FDA establishment listings and registration;
6. Prepare regulatory submissions, including technical files and design dossiers...