Role level 3, in Drug Devices Quality & Regulatory department, based in Eysins.
Your role:
Act as quality management representative in development projects for delivery systems for injectable drugs:
Ensure design control compliance. Identify applicable quality and regulatory requirements.
Review and approve all project deliverables. Review and approve labelling material. Participate to design reviews.
Compile the Technical Documentation, ensure CE mark approval. Lead the clinical evaluation effort, in collaboration with the medical team.
Support regulatory submission worldwide.
Lead the qualification and monitoring of suppliers.
Act as quality management representative for the maintenance of marketed medical devices:
Ensure compliance of the deviation and complaint handling processes. Lead the corrective and preventive action process. Perform the quality/regulatory assessment of proposed changes. Supervise the change control process.
Ensure continued compliance to new or revised regulations and standards.
Lead the post-market surveillance effort, in collaboration with the safety and complaint teams.Support regulatory submissions/renewals worldwide
Who you are
* Master, PhD or MD degree in science or related field
* Several years of experience in Quality, ideally in the field of medical devices
* Excellent knowledge of ISO 13485, 21 CFR 820, ISO 14971
* Excellent knowledge of medical device regulations, CE marking, 510 (k); 21 CFR 4 for combination products
* Fluent in English. Otherlanguages are an asset
* Ability to work on concurrent projects with a sense of ownership
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