R&D Device Design Control Lead
4 weeks ago
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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