Until · 1 month ago
Head of Quality & Regulatory Affairs
San Francisco, CA
Full-time
Onsite
Lead/Staff, Director/Executive
$180K/yr - $350K/yr
5+ years expUntil is seeking a Head of Quality & Regulatory Affairs to own and scale their quality system and regulatory strategy as they advance from pre-clinical development into clinical trials and early commercialization. This strategic and hands-on role involves designing and implementing a Quality Management System, defining regulatory pathways, and leading agency interactions while acting as the internal authority on quality, compliance, and risk.
BiotechnologyLife Science
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
Qualification
Required
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
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)
Company
Until
We are building reversible cryopreservation technology to solve the organ procurement and matching problem.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$106MKey Investors
Founders Fund
2025-09-22Series A· $58M
2024-06-06Series A· $48M
Leadership Team
Hunter Davis
Co-founder, CSO
Recent News
2025-11-28
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