Biomedical Device Development Manager

4 days ago


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

We are currently seeking a Biomedical Device Development Manager to join our team at Russell Tobin in Cambridge. As a key member of our team, you will be responsible for leading design control and risk management activities for combination product development programs.

The ideal 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 successful 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. Lead design control and risk management activities for combination product development programs
  2. Support the assessment of external design companies and suppliers
  3. Ensure compliance with quality and regulatory standards
  4. Collaborate with cross-functional teams


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