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 interfacesOwn quality governance including: SOPs, change control, CAPAs, deviations, complaints, Risk management (ISO 14971), Document control and training systemsServe as the final authority on quality decisions, balancing speed with compliance Lead internal audits and support external audits, inspections, and partner diligenceDefine 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 leadershipAdvise leadership on regulatory risk, sequencing, and trade-offsInterface 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 transferPartner closely with: R&D / Preclinical, Clinical, Manufacturing & Supply chain, Operations & Program ManagementAct as a translator between technical teams and regulatorsInitially 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)
