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Medical Device Auditor - France

Medical Device Auditor - France

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Medical Device Auditor - France

Medical Device Auditor
France (home based)

Do you want to build on the experience you have and learn what it really takes to get a device on to the market? Have you ever considered working for a notified body? MSI Pharma are representing a market leading MDR/ IVDR designated notified body who continues to grow. We are looking for individuals interested in a career as a Lead Medical Device Auditor and benefit from industry leading training and development.

Medical Device Auditors evaluate the quality management standard of ISO 13485 systems on our client's sites. The Medical Device Auditor is a client facing role and requires significant travel (up to 70%) to client sites in France and EMEA (when possible).

This role would allow you to work with different products and different manufacturers almost daily. This notified body works with the biggest names to small start ups working on a product that is going to revolutionise the industry. No two days would be the same!

** For this position ** We are looking for candidates with hands on experience of organic medical devices and/ or IVD (details below).


Core Responsibilities:

Evaluate the quality management standard of ISO 13485 systems on our client's sites
Writing and communicating your conclusions via understandable and clear reports and presenting them to clients.
Manage a portfolio of assigned clients
Participate in professional development and training opportunities to achieve necessary certifications and statuses
Attend training relating to ISO 13485 Lead auditor, MDSAP (Medical Device Single Audit Program) and MDR (Medical Device Regulation).

Requirements:

Bachelors, Masters or PhD in relevant science or engineering
4+ years medical device experience particularly those relating to organic and in vitro diagnosed devices
Work experience can be within: Research and development, manufacturing, service, testing
2+ years working in a quality management environment
Domestic and International travel (when possible) of up to 70%
French and English fluent



Specific areas of interest for this client:

Organic medical devices:

Chemical processing
Biotechnology
Processing of materials of human or animal origin
Non-metal, mineral processing (eg. glass, ceramics)
Non-metal, non-mineral processing (eg. textiles, rubber, leather, paper)
Production of pharmaceuticals

IVD:

IVD reagents, controls and/ or calibrators