Job Opportunities API

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