Regulatory Compliance Specialist
2 weeks ago
We are seeking a Regulatory Compliance Specialist to play a crucial role in ensuring regulatory compliance and driving consistency in medical device development projects. This role offers a unique insight into working in a cross-functional environment.
Key Responsibilities:
- Implement and maintain the design and development process, ensuring compliance with regulatory requirements and industry best practices.
- Develop and update design control documentation, including Design & Development Plans, Design Input Requirements, Traceability Matrixes such as design verification/validation reports.
- Drive continuous improvements in the Galderma 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.
Skills & Qualifications:
- 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 such as Pre-Clinical, CMC, Clinical, Manufacturing & Operations, Regulatory, Quality, and Commercial.
About Galderma:
Galderma is an organization that values diversity & inclusion and believes in delivering better outcomes by reflecting the perspectives of our diverse customer base.
As Galderma's Global Center of Excellence for Aesthetics, we have a unique edge in Uppsala with our whole product chain from research and development to production and marketing. Our nearly 600 employees work on our world-leading brands such as Restylane, Azzalure, and Sculptra.
We offer the opportunity to work in an exciting, international environment where both professional and personal development is encouraged. Our modern offices are located by the river Fyrisån, just a 10-minute bike ride from Uppsala Central Station.
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