VP of Regulatory Affairs

Lumicity; Fremont (CA); Hybrid; USD 160,000 - 250,000; Full time

Job summary

A fast-growing digital health startup is seeking a Vice President of Regulatory Affairs to lead global strategy and build the regulatory function from the ground up. This role involves ensuring compliance with FDA and international standards while managing submissions and engaging with key stakeholders. Ideal candidates will have extensive experience in regulatory affairs, specifically with medical devices, and a passion for innovation in healthcare.

Qualifications

• 15+ years in Regulatory Affairs, with 5+ years in medical devices.
• Proven track record in leading 510(k) or De Novo submissions.
• Strong communication skills with FDA engagement.

Responsibilities

• Define and lead global regulatory strategy for FDA and CE mark.
• Manage 510(k), De Novo, and technical file submissions.
• Oversee post-market activities including labeling and change control.

Skills

Regulatory Affairs

FDA QSR

ISO 13485

ISO 14971

IEC 62304

AI / ML frameworks

Cybersecurity

Leadership

Education

Advanced degree in a related field

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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