R&D Device Design Control Lead

1 month ago


Uppsala, Uppsala, Sweden Galderma Full time
Job Title: R&D Device Design Control Lead

We are seeking a highly skilled R&D Device Design Control Lead to join our team at Galderma. As a key member of our R&D 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 with cross-functional teams to drive continuous improvements in the Galderma design control process.
  • Participate in risk management activities, identifying, assessing, and mitigating risks in accordance with ISO 14971.
  • Provide expertise and support during audits, inspections, or inquiries from regulatory authorities.
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 and regulations such as EU MDR 2017/745 and 21 CFR 820.30.
What We Offer:

At Galderma, you'll work in an exciting, international environment where both professional and personal development is encouraged. We offer a unique opportunity to work on world-leading brands such as Restylane, Azzalure, and Sculptra.

We value diversity and inclusion, and we believe that our diverse team will deliver better outcomes by reflecting the perspectives of our diverse customer base.



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