Device Control Process Lead

4 days ago


Uppsala, Uppsala, Sweden TN Sweden Full time

We are seeking a highly skilled professional to fill the role of Device Control Process Lead at our Uppsala site. As a key member of our team, you will play a pivotal role in ensuring regulatory compliance and driving consistency across medical device development projects.

Key Responsibilities
  1. Develop and implement a robust design control process that adheres to industry best practices and regulatory requirements.
  2. Create and maintain comprehensive design control documentation, including Design & Development Plans, Design Input Requirements, and Traceability Matrixes.
  3. Promote continuous improvements in our design control process, striving for best-in-class efficiency and effectiveness.
  4. Collaborate with cross-functional teams to ensure seamless execution of development projects.
  5. Participate in risk management activities, identifying, assessing, and mitigating risks in accordance with ISO 14971.
  6. Support audits, inspections, or inquiries from regulatory authorities, providing expertise and guidance.
Requirements
  • Bachelor's or Master's degree in Life Sciences or a related field.
  • Substantial experience in device Design Control within the Life Science Industry.
  • Excellent written and verbal communication skills, with fluency in English.
  • Familiarity with GMP regulations is essential.
  • Proficiency in EU MDR 2017/745, 21 CFR 820.30, and ISO 13485 Quality Management System is required.
  • Desirable knowledge of Risk Management (ISO 14971) and Usability (IEC 62366) for Medical Devices.
  • Advantageous to have experience leading cross-functional teams and device development.
About Us

We value diversity and inclusion, believing that our unique perspectives deliver better outcomes. Our Galderma Global Center of Excellence for Aesthetics in Uppsala offers a one-of-a-kind environment where nearly 600 employees work on world-leading brands like Restylane, Azzalure, and Sculptra.

We offer a dynamic, international work environment that encourages both professional and personal growth. Our modern offices are located near the river Fyrisån in Uppsala, just a short bike ride from Uppsala Central Station.



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