Quality Assurance Specialist – Class IIb Medical Device

About the role

We are looking for an experienced Quality Assurance Specialist to lead risk management activities for a Class IIb medical device portfolio in Paris. The role is a 12‑month freelance assignment supporting backlog remediation, ongoing risk file maintenance and MDR‑related updates.

Key responsibilities

• Update and maintain risk management files (RMFs), including backlog items and historical CAPA‑related documentation.
• Perform routine RMF updates driven by non‑compliance events, post‑market surveillance data, health‑hazard evaluations and new product information.
• Provide risk management support to cross‑functional projects such as CRO, MORP and new product development.
• Deliver internal training sessions on risk‑management principles and regulatory requirements.
• Prepare and update RMFs for MDR submissions in line with EU MDR and ISO 14971.
• Respond to notified‑body queries concerning risk documentation.
• Support continuous‑improvement initiatives, including transferring risk data into databases and maintaining documentation within the eQMS.

Required profile

• Minimum 5 years of quality‑assurance experience in the medical‑device industry.
• Strong knowledge of ISO 14971, EU MDR and Quality Management System frameworks.
• Hands‑on experience with Class IIb (or higher) devices.
• Proven ability to manage complex RMF updates across multiple stakeholders.
• Self‑motivated contractor able to work autonomously in a fast‑paced regulatory environment.

Required skills

• ISO 14971
• EU MDR
• Quality Management System (QMS) implementation
• Risk Management Files (RMF) handling
• Electronic QMS (eQMS) tools