Head of Quality & Regulatory Affairs

We are seeking aHead of Quality & Regulatory Affairsto own and scale our quality system and regulatory strategy as we advance from pre-clinical development into clinical trials and early commercialization.This role isboth 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 ResponsibilitiesDesign, 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 complianceLead 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 / ICHire and develop QA and RA team members over timeEstablish external partner strategy (consultants, CROs, notified bodies, etc.)Build systems that will scale through clinical trials and toward commercializationQualifications5+ years of experience in Quality, Regulatory Affairs, or combined QA/RA in biotech, medtech, or combination productsDirect experience building or scaling a QMS in an early- or mid-stage companyHands‑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 frameworksTrack record of sound judgment in ambiguous, fast‑moving environmentsAbility to operate at both strategic and execution levelsPreferred / Nice to HaveExperience with IDE, first‑in‑human or novel modalitiesCombination product or platform technology experiencePrior inspection or audit leadership experienceExperience in organ preservation, devices, biologics, or translational research (context‑dependent)$180,000 - $350,000 a year#J-18808-Ljbffr