Job description
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
Lead preparation and submission of FDA 510(k) filings for healthcare software and digital health products
Develop and execute regulatory strategies supporting product development and commercialization
Collaborate with product development, quality, clinical, and engineering teams to ensure regulatory compliance
Interpret FDA guidance related to medical device software and digital health technologies
Partner with global regulatory teams to support international regulatory initiatives
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
Strong cross-functional collaboration and communication skills
Originally posted on Himalayas
Who can apply
Eligible countries: United States. Accepted UTC offsets: UTC-10, UTC-9, UTC-8, UTC-7, UTC-6, UTC-5, UTC+14. Review the full description for employer-specific work authorization, residency and schedule requirements.