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Regulatory Compliance Expert
1 month ago
We are seeking a Regulatory Compliance Expert to join our team at Russell Tobin in Cambridge. This is a 12-month contract with a maximum PAYE rate of £21.62 per hour and an umbrella rate of up to £24.23 per hour.
The successful candidate will have a strong background in design control and risk management, with experience working in the pharmaceutical combination product and/or device industries. A BSc or MSc in an appropriate science or engineering discipline is required, as well as a minimum of 2 years of relevant experience.
The role will involve supporting the assessment of external design companies and suppliers, ensuring compliance with quality and regulatory standards, and collaborating with cross-functional teams.
The ideal candidate will be able to generate regulatory submission data and content, support device design and manufacturing investigations, and work effectively in a fast-paced environment.
Key skills and qualifications include:
- Working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, and the EU Medical Devices Regulation
- Familiarity with EN 62366, EN 60601, and EN 62304
- Able to learn and apply established procedures in a reliable and consistent manner
- High level of attention to technical details and accuracy
We offer a competitive salary and benefits package, as well as opportunities for professional development and growth.
This is a fantastic opportunity for a motivated and experienced individual to join our team and contribute to the success of our company.
Requirements:
- BSc or MSc in an appropriate science or engineering discipline
- Minimum of 2 years of relevant experience in the pharmaceutical combination product and/or device industries
- Strong background in design control and risk management
Responsibilities:
- Support the assessment of external design companies and suppliers
- Ensure compliance with quality and regulatory standards
- Collaborate with cross-functional teams
- Generate regulatory submission data and content