VP, Regulatory Affairs

FOUND; United States; On-site; USD 250,000 - 400,000; Full time

Job summary

FOUND seeks a VP of Regulatory Affairs to drive global regulatory strategy for its pharmaceutical, biologic, and medical device portfolio, including combination products. This senior leader reports to the CEO/COO and oversees regulatory submissions, inspections readiness, and cross-functional alignment with Quality, Clinical, R&D, and Commercial teams.

The role requires deep hands-on medical device regulatory experience (510(k), De Novo, PMA, EU MDR) in addition to pharmaceutical regulatory

Qualifications

• Bachelor's degree in a scientific, engineering, or regulatory discipline; advanced degree or RAC strongly preferred.
• Extensive regulatory experience spanning pharma/biologic and medical device pathways, including combination products.
• Proven track record with FDA and global health authorities, including pre-submission meetings and negotiations.

Responsibilities

• Develop and execute global regulatory strategy across pharmaceutical and medical device pathways.
• Lead primary liaison activities with FDA and other health authorities.
• Own submissions: INDs/NDAs/BLAs and 510(k)/De Novo/PMA as applicable.
• Guide product design, labeling, clinical trials, and risk management to ensure compliance.
• Build and mentor a growing regulatory affairs team and cross-functional partnerships.

Skills

Regulatory leadership

FDA interactions

Device and combination product

Strategic regulatory planning

Cross-functional leadership

Regulatory compliance

Education

Bachelor's degree in science/engineering/regulatory field

MS/PhD or RAC certification preferred

Job description

Our client is a growth-stage pharmaceutical and medical device company.

About the Role

Our client is seeking a VP, Regulatory Affairs to lead global regulatory strategy across its combination product and device portfolio. This is a highly visible, senior leadership role reporting directly to the CEO/COO, responsible for building and scaling the regulatory function as the company advances products through clinical development, FDA submissions, and commercialization. The ideal candidate brings deep, hands-on experience navigating both pharmaceutical and medical device regulatory pathways — medical device regulatory experience is required, not preferred.

Responsibilities

• Develop and execute global regulatory strategy across the product portfolio, spanning both pharmaceutical (drug/biologic) and medical device (including combination product) pathways.
• Serve as primary liaison to FDA and other health authorities (EMA, Health Canada, etc.), leading pre-submission meetings, responses to agency requests, and ongoing regulatory correspondence.
• Own preparation, review, and submission of regulatory filings, including INDs/NDAs/BLAs as applicable, and 510(k), De Novo, or PMA submissions for device components.
• Lead regulatory input into product design, labeling, clinical trial design, and risk management to ensure compliance with FDA, ISO 13485, IEC 60601, and applicable QSR/EU MDR requirements.
• Build, mentor, and manage a growing regulatory affairs team as the company scales.
• Partner cross-functionally with Quality, Clinical, R&D, and Commercial leadership to align regulatory strategy with business objectives and timelines.
• Monitor evolving regulatory landscape and guidance (FDA, ISO, MDR/IVDR) and advise leadership on emerging risks and opportunities.
• Maintain regulatory files, technical documentation, and audit-readiness in support of inspections and notified body reviews.
• Represent regulatory affairs in due diligence activities, licensing discussions, and partnership evaluations as needed.

Qualifications

• Bachelor's degree in a scientific, engineering, or regulatory-related discipline (advanced degree — MS, PhD, PharmD, or RAC certification — strongly preferred).
• 12+ years of progressive regulatory affairs experience, including at least 5+ years in a senior leadership role (VP, Sr. Director, or equivalent).
• Required: direct, hands-on medical device regulatory experience — including 510(k), De Novo, PMA, and/or EU MDR submissions — in addition to pharmaceutical/biologic regulatory experience. Candidates with pharma-only backgrounds and no device experience will not be considered.
• Demonstrated track record leading successful interactions with FDA and other global health authorities, including pre-submission meetings and agency negotiations.
• Deep working knowledge of FDA regulations (21 CFR Parts 800s/820, QSR), ISO 13485, ISO 14971, IEC 60601, and combination product regulatory frameworks (21 CFR Part 4).
• Experience building and leading regulatory teams, with strong cross-functional leadership and communication skills.
• Proven ability to operate in a fast-paced, growth-stage environment and translate regulatory strategy into practical, business-aligned execution.

Required Skills

• Direct, hands-on medical device regulatory experience — including 510(k), De Novo, PMA, and/or EU MDR submissions — in addition to pharmaceutical/biologic regulatory experience.
• Demonstrated track record leading successful interactions with FDA and other global health authorities, including pre-submission meetings and agency negotiations.
• Deep working knowledge of FDA regulations (21 CFR Parts 800s/820, QSR), ISO 13485, ISO 14971, IEC 60601, and combination product regulatory frameworks (21 CFR Part 4).
• Experience building and leading regulatory teams, with strong cross-functional leadership and communication skills.
• Proven ability to operate in a fast-paced, growth-stage environment and translate regulatory strategy into practical, business-aligned execution.

Preferred Skills

• RAC (Regulatory Affairs Certification) through RAPS.
• Prior experience at a growth-stage or venture-backed company that scaled its regulatory function from the ground up.
• Experience with international market expansion (EU MDR, Health Canada, other ex-US markets).
• Familiarity with digital health, SaMD (Software as a Medical Device), or connected device regulatory considerations.
• Experience supporting M&A due diligence or licensing transactions from a regulatory perspective.

Pay range and compensation package

Reporting Structure & Location

Equal Opportunity Statement

Our client is committed to providing equal employment opportunities and to building an inclusive, diverse work environment. All qualified applicants will receive consideration for employment without regard to any protected characteristic or status.