Job Description

We are seeking a Head of Quality & Regulatory Affairs to own and scale our quality system and regulatory strategy as we advance from pre-clinical development into clinical trials and early commercialization.

This role is both strategic and hands-on . You will design and implement a fit-for-purpose QMS, define regulatory pathways, lead agency interactions, and act as the internal authority on quality, compliance, and risk. You will be a core member of the leadership team and a key partner to R&D, Manufacturing, Clinical, and Operations.

Key Responsibilities

• Design, implement, and maintain a scalable Quality Management System (QMS) aligned with: FDA (21 CFR 820, 21 CFR 210/211 as applicable), ISO 13485 / ISO 9001 (as appropriate), GLP / GCP / GMP interfaces
• Own quality governance including: SOPs, change control, CAPAs, deviations, complaints, Risk management (ISO 14971), Document control and training systems
• Serve as the final authority on quality decisions, balancing speed with compliance
• Lead internal audits and support external audits, inspections, and partner diligence
• Define and own the regulatory strategy across product lines (device, biologic, combination product, or hybrid pathway as applicable)
• Lead FDA interactions including: Pre-Subs / Q-Subs, IND / IDE strategy (as applicable), briefing documents and meeting leadership
• Advise leadership on regulatory risk, sequencing, and trade-offs
• Interface with global regulators as needed (EMA, MHRA, etc.)
• Embed quality and regulatory thinking early into: R&D and preclinical study design, manufacturing process development, vendor qualification and tech transfer
• Partner closely with: R&D / Preclinical, Clinical, Manufacturing & Supply chain, Operations & Program Management
• Act as a translator between technical teams and regulators
• Initially operate as a player-coach / IC
• Hire and develop QA and RA team members over time
• Establish external partner strategy (consultants, CROs, notified bodies, etc.)
• Build systems that will scale through clinical trials and toward commercialization

Qualifications

• 5+ years of experience in Quality, Regulatory Affairs, or combined QA/RA in biotech, medtech, or combination products
• Direct experience building or scaling a QMS in an early- or mid-stage company
• Hands‑on experience leading FDA interactions (Pre-Sub, IND, IDE, or equivalent)
• Strong working knowledge of: FDA regulations (21 CFR 820, 210/211, 11 as relevant), ISO 13485 and risk management frameworks
• Track record of sound judgment in ambiguous, fast‑moving environments
• Ability to operate at both strategic and execution levels

Preferred / Nice to Have

• Experience with IDE, first‑in‑human or novel modalities
• Combination product or platform technology experience
• Prior inspection or audit leadership experience
• Experience in organ preservation, devices, biologics, or translational research (context‑dependent)

$180,000 - $350,000 a year

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