Regulatory Affairs Manager-US

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