Quality Assurance Manager, Medical Device & Combination Products
Core
Strategic quality oversight for Medical Device and Combination Products (MDCP) portfolios across 50+ markets, ensuring compliance with international regulatory standards and patient safety.
Role type
Senior IC Quality Assurance Manager (Medical Device & Combination Products)
Builds
Global quality systems, compliant delivery platforms, and risk-based decision frameworks for MDCP assets.
Domain
Medical Devices, Combination Products, Pharmaceuticals, Regulatory Compliance
Required skills
Quality Assurance, GMP manufacturing, Design Controls, Risk Management, Regulatory Compliance (ISO 13485, ISO 14971, EU MDR, 21 CFR Part 4, FDA 21 CFR 820), Post-market Surveillance, Change Control, Supplier Management, Process Validation, CAPA
Preferred skills
Combination product regulations, Post-approval changes, Manufacturing transfers, Usability engineering, Software validation, Cross-functional leadership
Technologies
ISO 13485, ISO 14971, EU MDR, 21 CFR Part 4, FDA 21 CFR 820
Responsibilities
Lead global quality assurance oversight for multiple concurrent MDCP programs; Provide authoritative guidance on design controls, post-approval changes, and manufacturing transfers; Drive resolution of complex multi-regional quality and compliance issues; Monitor shifting international regulations and translate them into unified global policies; Evaluate investigation content and CAPA relevance; Strengthen processes and advance quality system maturity across the product lifecycle.
Seniority
Senior, hands-on IC