Regulatory Affairs Manager
Posted 12 Mar 2026
Advertised as “Regulatory Affairs Manager-US”
BranchFactor Summary
The original posting with the fluff stripped out
- Expected experience
- 5–10 yrs
- Management level
- People management
- Employment
- Remote
No salary listed for this role.
Symmetrio is recruiting for our client for a Regulatory Affairs Manager to lead U.S. regulatory strategy and submissions for innovative healthcare software products. This role will focus on FDA 510(k) submissions and regulatory pathways for Software as a Medical Device (SaMD) within a global, multinational environment.
Key Responsibilities
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Lead preparation and submission of FDA 510(k) filings for healthcare software and digital health products
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Develop and execute regulatory strategies supporting product development and commercialization
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Collaborate with product development, quality, clinical, and engineering teams to ensure regulatory compliance