Medical Device Regulatory and Quality Consultant
Core
Consultant advising clients on regulatory, quality, and compliance aspects of medical devices, SaMD, and combination products.
Role type
Senior IC medical device regulatory and quality consultant
Builds
Regulatory compliance strategies and optimized Quality Management Systems (QMS) for MedTech and pharmaceutical clients
Domain
Healthcare & Life Sciences (MedTech, Pharmaceuticals)
Deliverable
client delivery
Required skills
Global regulatory framework expertise (FDA, EMA, MDR/IVDR, ISO 13485, IEC 62304, ISO 14971), QMS development and optimization, risk management, requirements traceability, cross-functional technical leadership, project management
Preferred skills
Experience with AI-driven medical technologies, hardware/software integration knowledge
Technologies
ISO 13485, ISO 14971, IEC 62304, GAMP, 21 CFR 4/820
Responsibilities
Guide hardware, software, and AI-driven medical device development for regulatory compliance; Lead risk management activities; Develop and optimize client QMS; Advise cross-functional engineering teams on compliance best practices; Ensure requirements traceability from user needs through validation; Facilitate collaboration between engineering, quality, and regulatory disciplines
Seniority
Senior, hands-on IC
