Senior Regulatory Affairs Specialist
Alphatec Spine
Carlsbad, california
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:
- 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;
- Support design control activities for spinal devices, medical software (SaMD), medical devices containing software, and radiation emitting devices;
- Apply IEC 62304 requirements during the development and improvement of the software lifecycle process for domestic and OUS submissions;
- Prepare regulatory submissions, including 510(k) premarket notifications for the FDA;
- Maintain FDA establishment listings and registration;
- Prepare regulatory submissions, including technical files and design dossiers...