Regulatory Affairs Manager-US

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