Quality Assurance and Regulatory Affairs Manager
Core
Own the end-to-end Quality Management System (QMS) for a novel diagnostic device, ensuring FDA 21 CFR Part 820 compliance and supporting manufacturing and regulatory teams.
Role type
Quality Assurance and Regulatory Affairs Manager
Builds
FDA-compliant diagnostic devices (Hormometer®)
Domain
Medical devices / Diagnostics / Regulated industries
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
QMS process ownership, FDA 21 CFR Part 820 compliance, supplier qualification, audit coordination, electronic QMS management, design history file maintenance, CAPA management, change control, document control, training record management, regulatory first-principles thinking, rigorous documentation, cross-functional collaboration
Preferred skills
Experience with physical consumables, reagents, or laboratory supply chains
Technologies
Electronic Quality Management Systems (eQMS)
Responsibilities
Run core QMS processes (document control, change control, non-conformances, CAPA, training, equipment management), maintain electronic QMS, update design and production documentation, manage supplier qualification and audits, coordinate internal and external audits, train employees on QMS and regulations, define and meet quality policies with CTO
Seniority
Mid-level, hands-on IC