Senior Regulatory Specialist

SPCSHP is an Agency of Progress, applying intelligence, creativity, and craft to help clients understand themselves, their customers, and the larger culture. Regardless of the size of the organization or where they are on their journey, they all must move forward. For some, this requires incremental change. For others, transformation. SPCSHP is designed to build brands the way people experience them – where Stories, Systems, and Communities meet. Our client relationships span different industries and brand life stages: from start-ups like Lightricks to established Fortune 500 companies like JPMorgan Chase, Dairy Queen, PepsiCo, and Starbucks, among others.

The Senior Specialist, Regulatory Affairs (Advertising and Promotion) will support the promotional material review and approval process for advertising created at SPCSHP. The Senior Specialist will be responsible for managing all legal and regulatory submissions related to healthcare and pharmaceutical advertising...

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...