Head of Quality & Regulatory Affairs

Until(1 month ago)

Bay AreaOnsiteFull TimeDirector$204,439 - $271,924 (estimated)Quality and Regulatory Affairs

About this role

The Head of Quality & Regulatory Affairs will own and scale the company’s quality system and regulatory strategy as it moves from pre-clinical development into clinical trials and early commercialization. This role sits on the leadership team and serves as the internal authority on quality, compliance, and regulatory risk. The position requires operating at both strategic and hands-on levels while partnering closely with R&D, Clinical, Manufacturing, and Operations. The leader will build the function and team, developing systems that can support growth through clinical development and commercialization.

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Required Skills

Quality Management System
Regulatory Strategy
FDA Regulations
ISO 13485
ISO 9001
GLP Compliance
GCP Compliance
GMP Compliance
SOP Management
Change Control

+15 more

Qualifications

5+ years in Quality or Regulatory Affairs

About Until

untillabs.com

Until is a biotechnology company building a “pause button” for biology by developing reversible cryopreservation technologies so transplantable organs (and ultimately whole bodies) can be preserved until a recipient is found. Their work aims to extend organ viability, reduce organ wastage, and improve transplant access through new preservation tools, protocols, and engineering approaches. Until has assembled a multidisciplinary team and raised $48M to advance scalable, clinically translatable cryopreservation solutions.