Director, Regulatory Affairs Medical Device

Director, Regulatory Affairs-Medical Device

Early-Stage Cardiovascular Device Company | PMA Pathway | San Francisco Bay Area (Hybrid)

Position Summary

Title: Director, Regulatory Affairs Medical Device

Company: Cardiovascular medical device startup

Location: East Bay, California (680 corridor); hybrid, 2–3 days on-site per week

Reports To: Chief Executive Officer

Employment Type: Full-time

Stage: Seed / post-seed cardiovascular medical device company

Our client is an early-stage cardiovascular medical device company preparing to advance its lead technology toward a Premarket Approval (PMA) submission with the U.S. FDA and subsequent entry into the EU market. After a successful seed round, the company is closing its next funding round and building a small, hands-on leadership team to carry the program to its next value inflection point.

The Director, Regulatory Affairs, will be the company’s first dedicated regulatory hire and will own end-to-end execution of the regulatory plan. Working alongside external regulatory experts and a leadership team with deep quality-systems and document-control experience, this individual will translate regulatory strategy into pre-submissions, submissions, and agency interactions, and will have the standing and experience to challenge that strategy when their own experience indicates a more robust path.

This is a builder’s role. No regulatory department exists to inherit; the Director will establish it. The right candidate has lived through the full arc of a Class III device program and wants the ownership, breadth, and pace that only an early-stage company can offer.

Key Responsibilities:

Regulatory Strategy & Execution

• Own end-to-end execution of the U.S. regulatory pathway for a Class III cardiovascular device, including PMA planning, module structuring, authoring, compilation, and submission.
• Lead FDA Pre-Submission (Q-Sub) preparation, including briefing packages, question framing, meeting preparation, and follow-through on agency feedback.
• Partner with the company’s regulatory strategy consultant to refine the overall strategy; bring independent judgment and push back where prior experience indicates risk in a proposed approach.
• Develop and maintain the regulatory plan, milestone timeline, and risk register aligned to the company’s funding and development roadmap.
• Define the EU/EMA regulatory pathway (MDR, Notified Body engagement, technical documentation) and plan for international submissions as the program matures.

Agency Interactions & Submissions

• Serve as primary point of contact with FDA and, as applicable, Notified Bodies and international health authorities.
• Prepare, review, and submit IDE applications, amendments, supplements, and annual reports as required to support clinical investigation.
• Manage submission logistics through the FDA eSTAR/eCopy process and maintain a complete, audit-ready regulatory history file.
• Coordinate responses to agency deficiency letters and information requests within required timelines.

Cross-Functional Leadership

• Provide regulatory input to design and development, preclinical and biocompatibility testing, clinical study design, labeling, and risk management (ISO 14971).
• Work closely with the quality function to ensure the QMS (21 CFR 820/ISO 13485) and design controls generate the evidence a PMA will require.
• Review technical reports, protocols, and test data for regulatory adequacy before they are locked.
• Serve as regulatory reviewer for controlled documents.
• Monitor regulatory intelligence—guidance documents, standards, and precedent PMA decisions in the cardiovascular space—and advise leadership on impact.

Building the Function

• Establish regulatory SOPs, templates, and document practices from the ground up, scaled appropriately for a lean company.
• Manage external regulatory consultants, writers, and vendors as needed.
• Scale the function over time, including hiring and mentoring regulatory staff as the company grows.

Required Qualifications

• Minimum of 10 years of medical device regulatory affairs experience, with progressive responsibility through senior manager, associate Director, or director-level roles.
• Hands-on PMA experience is required: direct authorship and compilation of PMA content and management of the submission process through to FDA review (Candidates with limited exposure to a single module or a single functional slice of a larger team will not meet the bar for this role).
• Demonstrated experience leading FDA Pre-Submissions and agency meetings, including preparing briefing materials and managing follow-up.
• Experience with EU regulatory submissions (MDR/MDD technical documentation, Notified Body interactions, CE marking).
• Working knowledge of IDE requirements and the regulatory aspects of clinical investigations for Class III devices.
• Strong command of 21 CFR Parts 812, 814, and 820; ISO 13485; ISO 14971; and applicable device standards.
• Bachelor’s degree in engineering, life sciences, or a related discipline; advanced degree or RAC certification a plus.
• Located in the San Francisco Bay Area or Central Valley region. This role requires a regular weekly on-site presence and cannot be performed fully remotely.

Preferred Qualifications

• Cardiovascular implant experience.
• Prior experience as the first or sole regulatory professional at a startup, or as a senior leader who rose through the ranks at a larger device company and retained hands-on execution skills.
• Track record of taking a Class III program from early development through PMA approval.
• Experience with Breakthrough Device Designation, Early Feasibility Studies, or other expedited pathways.

Who Thrives Here

The company is deliberately lean and will remain so for the next year or more. The company’s leadership values who a person is as much as what they know, and is looking for the following traits in every critical hire:

• Self-starter: comfortable operating without a fully built-out SOP library or a large team, and willing to create structure rather than wait for it.
• Hands-on: does the work personally, from authoring submission sections to managing the submission.
• Self-aware and coachable: candid about what they don’t know, and eager to learn from a leadership team with deep quality and operational experience.
• Comfortable with ambiguity: makes sound decisions with incomplete information and adjusts as the program evolves.
• Driven by ownership: wants to see a program through from strategy to approval rather than contribute to a single phase.
• Team-oriented: steps in when a build, a deadline, or a colleague needs help, and expects the same flexibility in return.