Medical Device Quality Specialist Consultant
Core
Consultant supporting global organizations in the design, development, and life-cycle management of medical devices, combination products, and SaMD to ensure regulatory compliance and product safety.
Role type
Senior Medical Device Quality Specialist Consultant
Builds
Regulatory-compliant medical devices, combination products, and SaMD for global markets
Domain
Life Sciences / Medical Devices / Regulatory Affairs
Deliverable
client delivery
Required skills
Quality Management Systems (ISO 13485, QMSR), Design History Files, Risk Management (ISO 14971), Supplier Audits, Technical Documentation, SaMD Lifecycle (IEC 62304), Combination Product Regulations, Technology Transfer, Post-Market Surveillance
Preferred skills
Management consultancy experience, Drug-device/Biologic-device combination product knowledge, CCIT, Stability/compatibility studies
Technologies
ISO 13485, QMSR, ISO 14971, IEC 62304, IEC 82304, 21 CFR Part 4, UK MDR, EU MDR
Responsibilities
Advise on quality and regulatory requirements for medical devices and SaMD; Author and maintain quality and technical documentation; Support supplier qualification and audits; Lead risk management activities; Support technology transfer and process validation; Manage quality deliverables in cross-functional project teams
Seniority
Senior, hands-on IC with strategic advisory component
