R&D Device Design Control Lead

2 months 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 medical device development team, you will play a crucial role in ensuring regulatory compliance, driving consistency, and enhancing the efficiency of our projects.

Key Responsibilities

  • Develop and maintain design and development processes, ensuring compliance with regulatory requirements and industry best practices.
  • Implement and update design control documentation, including Design & Development Plans, Design Input Requirements, and Traceability Matrixes.
  • Drive continuous improvements in our design control process, striving for best-in-class efficiency and effectiveness.
  • Coordinate and facilitate cross-functional team meetings related to design control throughout all stages of development projects.
  • 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.
  • Participate as necessary during audits, inspections, or inquiries from regulatory authorities, providing expertise and support.

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.
  • Desired knowledge in Risk Management ISO 14971/ISO 24971 and Usability IEC 62366 for Medical Devices.
  • Advantageous to have experience in device development and leading cross-functional teams across various functions.

What We Offer

At Galderma, we value diversity and inclusion, and we believe that our diverse team is essential to delivering better outcomes for our customers. We offer a unique opportunity to work in an exciting, international environment where professional and personal development is encouraged.

We are a global company with a strong presence in the medical device industry, and we are committed to providing our employees with a supportive and collaborative work environment. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.

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