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Drug Delivery Device Quality Lead Expert (all genders)
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.
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!
Apply now and become a part of our diverse team!
US Equal Employment Opportunities
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
We are committed to an equitable hiring process for candidates from a diverse range of backgrounds. As part of this commitment, applicants with disabilities may be entitled to reasonable accommodations. Please contact USLeavesandAccommodations@milliporesigma.com, if a reasonable accommodation is needed or if you otherwise need assistance to participate in the hiring process.
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