Job Description

Location: Hybrid – San Francisco Bay Area (3 days onsite)

Company Overview

Our client, a fast-growing digital health and SaMD startup, is developing AI-powered software that turns everyday devices into clinical-grade diagnostics. With several Class II devices in the pipeline, they’re looking for a Vice President of Regulatory Affairs to lead global regulatory strategy and build the regulatory function from the ground up.

Key Responsibilities

• Define and lead global regulatory strategy (FDA, CE mark, Health Canada, etc.)
• Manage 510(k), De Novo, and technical file submissions
• Serve as the primary point of contact with FDA and other agencies
• Partner with product, clinical, quality, and engineering teams to ensure compliance
• Oversee post-market activities: labeling, surveillance, and change control
• Build regulatory processes and team infrastructure
• Provide input on clinical trials and software lifecycle
• Represent regulatory in board meetings and due diligence

Must-Have Qualifications

• 15+ years in Regulatory Affairs, with 5+ years in medical devices (Class II preferred)
• Proven track record leading 510(k) or De Novo submissions
• Deep knowledge of FDA QSR, 21 CFR 820, ISO 13485, ISO 14971, IEC 62304
• Experience with software documentation, AI/ML frameworks, and cybersecurity
• Strong communicator with experience engaging FDA and internal stakeholders
• History of scaling regulatory functions in startup settings

Preferred Qualifications

• International submission experience (EU MDR/IVDR, Health Canada, APAC)
• Background in diagnostics, biosensors, or cognitive/cardiac health
• Familiarity with Breakthrough Device or STeP programs
• Prior leadership of regulatory teams
• Advanced degree in a related field

Next Steps

If you’re excited to lead regulatory strategy in a mission-driven, fast-paced environment, we’d love to connect. Apply now and our Talent team will be in touch.

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