Regulatory Affairs Manager-US

- 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

- 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