Drug Delivery Device Quality Lead Expert

vor 5 Monaten

Eysins, Schweiz Merck KGaA Darmstadt Germany Vollzeit

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you've got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

**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. Other languages are an asset

**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress

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