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Regulatory Affairs Manager-US

Symmetrio

Remote

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About the role

Symmetrio is seeking a Regulatory Affairs Manager to oversee U.S. regulatory strategies and submissions for healthcare software products, specifically focusing on FDA 510(k) filings and regulatory pathways for Software as a Medical Device (SaMD). The role involves preparing and submitting FDA filings, developing regulatory strategies to support product development and commercialization, and collaborating with various teams, including product development, quality, clinical, and engineering, to ensure compliance with regulations. Candidates should have 5 to 10 years of experience in regulatory affairs related to medical devices or healthcare software, with a proven track record in FDA 510(k) submissions for software-based medical devices. A strong understanding of SaMD, FDA regulations, and relevant quality standards is essential. Experience in a multinational organization is also required, along with excellent collaboration and communication skills. This position is remote, making it suitable for individuals who thrive in a flexible work environment.

The advert

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

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