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Regulatory Compliance Expert

1 month ago


Cambridge, Cambridgeshire, United Kingdom Russell Tobin Full time
About the Job

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:

  1. Support the assessment of external design companies and suppliers
  2. Ensure compliance with quality and regulatory standards
  3. Collaborate with cross-functional teams
  4. Generate regulatory submission data and content
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