
Device Control Process Lead
4 days ago
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- Develop and implement a robust design control process that adheres to industry best practices and regulatory requirements.
- Create and maintain comprehensive design control documentation, including Design & Development Plans, Design Input Requirements, and Traceability Matrixes.
- Promote continuous improvements in our design control process, striving for best-in-class efficiency and effectiveness.
- Collaborate with cross-functional teams to ensure seamless execution of development projects.
- Participate in risk management activities, identifying, assessing, and mitigating risks in accordance with ISO 14971.
- Support audits, inspections, or inquiries from regulatory authorities, providing expertise and guidance.
- 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.
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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