R&D Device Design Control Lead

4 weeks ago


Uppsala, Uppsala, Sweden Galderma Full time

Job Summary

We are seeking a highly skilled R&D Device Design Control Lead to join our team at Galderma. As a key member of our design control team, you will play a crucial role in ensuring regulatory compliance, driving consistency, and enhancing the efficiency of medical device development projects.

Key Responsibilities

  • Develop and maintain the design and development process, ensuring compliance with regulatory requirements and industry best practices.
  • Collaborate closely with cross-functional teams to ensure the successful execution of development projects.
  • Participate in risk management activities, identifying, assessing, and mitigating risks.
  • Provide expertise and support during audits, inspections, or inquiries from regulatory authorities.
  • Develop and update design control documentation, including Design & Development Plans, Design Input Requirements, and Traceability Matrixes.

Requirements

  • Master's or Bachelor's degree in Life Sciences or related discipline.
  • Several years of experience in device Design Control within the Life Science Industry.
  • Fluent in English with strong written and verbal communication skills.
  • Experience with GMP is required.
  • Proficiency in regulations such as EU MDR 2017/745 and 21 CFR 820.30, as well as ISO 13485 Quality Management System is required.

What We Offer

As a Galderma employee, you will have the opportunity to work in an exciting, international environment where both professional and personal development is encouraged. We offer a competitive salary and benefits package, as well as opportunities for career growth and advancement.

Next Steps

If your profile matches our requirements, we will invite you for a first virtual conversation with the recruiter. The next step is a virtual conversation with the hiring manager, followed by a panel conversation with the extended team.



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