Device Design Control Lead

6 days ago


Uppsala, Uppsala, Sweden TN Sweden Full time

We are seeking a highly skilled R&D Device Design Control Lead to join our team in Uppsala. This role will play a crucial part in ensuring the medical device development projects at Galderma comply with regulatory requirements.

Key Responsibilities
  • Develop and maintain design control documentation, including Design & Development Plans, Design Input Requirements, Traceability Matrixes, and design verification/validation reports.
  • Implement and drive continuous improvements in the Galderma design control process, striving for best-in-class efficiency and effectiveness.
  • Collaborate closely with Project Managers, Project Risk Managers, and Chief Design Experts to ensure the successful execution of development projects.
  • Participate in risk management activities in accordance with ISO 14971, identifying, assessing, and mitigating risks.
Required Skills and Qualifications
  1. Master's or Bachelor's degree in Life Sciences or related discipline.
  2. Several years of experience in device Design Control within the Life Science Industry.
  3. Fluent in English with strong written and verbal communication skills.
  4. Experience with GMP is required.
  5. Proficiency in regulations such as EU MDR 2017/745 and 21 CFR 820.30, as well as ISO 13485 Quality Management System is required.


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