Job Description
Until is a moonshot company building a “pause button” for biology. Our near-term focus is organ-scale reversible cryopreservation: preserving donated organs at subzero temperatures without ice formation, then rewarming them uniformly for transplant. By solving this grand challenge, we’re laying the foundation for whole-body reversible cryopreservation, giving patients a bridge to future cures.
To achieve our goal, we are assembling an interdisciplinary team to develop perfusion systems, cryoprotectant formulations, and vitrification and rewarming hardware.
We envision a future where no transplantable organ is lost to logistics, and no terminal diagnosis is final because patients can safely wait for future medicine to arrive.
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)
