Regulatory Affairs Manager-US
SymmetrioUnited States
Posted March 12, 2026
Full Time
About the Company
Symmetrio is a full-service talent solutions firm that delivers staffing, recruiting, executive search, and consulting across technology, life sciences, and healthcare sectors. The company structures its teams around specialized practice areas, staffed by industry veterans who bring operational expertise to every engagement. Symmetrio combines permanent placement, contract staffing, and project-based augmentation with strategic consulting to help clients navigate shifting economic conditions and align talent with culture and business objectives. By positioning itself as a trusted advisor rather than a mere recruiter, Symmetrio offers customized, long-term partnership solutions that support clients' growth and resilience.
Job Description
Regulatory Affairs Manager to lead U.S. regulatory strategy and submissions for innovative healthcare software products.
Requirements
- 5–10+ years of regulatory affairs experience in medical devices or healthcare software
- Proven experience with FDA 510(k) submissions, ideally for software-based medical devices
- Strong knowledge of SaMD, FDA regulations, and quality standards (21 CFR Part 820, ISO 13485, IEC 62304)
- Experience working within a multinational organization
