# Senior Regulatory Affairs Specialist at Hyperfine Research

- Company: Hyperfine Research
- What the company does: The Hyperfine, Inc. Swoop® Portable MR Imaging® system brings brain imaging to the patient at the point of care. Backed by GV.
- Company website: https://www.hyperfinemri.com
- Type: Startups
- Level: Senior
- Location: Guilford, Connecticut
- Work setup: On-site
- Pay: $145K to $167K base salary per year (USD)
- Posted: 2025-12-22
- Apply by: 2026-10-12
- Apply: https://job-boards.greenhouse.io/hyperfine53/jobs/5742948004
- Page: https://www.1752.vc/careers/jobs/hyperfine-research-senior-regulatory-affairs-specialist/

## About the role

Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions.

## What they're looking for

- Bachelor’s degree in a scientific or regulatory discipline, plus 8 years' experience in the medical device industry, or equivalent work experience
- Minimum 5 years' experience in Regulatory Affairs role
- Experience interpreting FDA and international guidelines and regulations
- History of successful US FDA 510(k) clearances for Class II devices and interactions with regulators
- Experience with EU MDR, Health Canada, and Australia TGA regulatory submissions
- Experience with international registrations

Tags: Regulatory