Product Quality Lead - Drug Delivery Devices

Posted 10 Mar 2020

Aubonne, Vaud - Switzerland

Req Id 204280

Details

A career at our company is an ongoing journey of discovery: our around 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


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
  • 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. Other main European languages would be an asset

What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

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