At a glanceSummarised by Seekless from the posting.
Must have5
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
About the role
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.
Responsibilities
Key Responsibilities
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Lead preparation and submission of FDA 510(k) filings for healthcare software and digital health products
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Develop and execute regulatory strategies supporting product development and commercialization
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Collaborate with product development, quality, clinical, and engineering teams to ensure regulatory compliance
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Interpret FDA guidance related to medical device software and digital health technologies
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Partner with global regulatory teams to support international regulatory initiatives
Requirements
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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