Senior Compliance Engineer

Job Reference: WM – 2298

Location: Cambridge

Salary: £60,000 - £70,000

Job Type: Permanent

Job Description

Senior Compliance Engineer

Brief Role Description:

We are supporting our client who are a successful manufacturer of Safety Critical Components, in their search for a Senior Compliance Engineer to join their expanding team.

Responsibilities:

  • Pragmatically driving all aspects of compliance across a multi-disciplinary team responsible for medical device development throughout the full development lifecycle
  • Working with the Regulatory team to understand which standards are applicable across global markets of interest
  • Proactively tracking standards to inform design teams of potential design or risk changes and ensuring that internal specifications and requirement documents reflect any updates
  • Compiling and maintaining a comprehensive mapping between clauses in standards and their applicability to the design
  • Highlighting and assisting coordination of compliance related activities for risk, verification or vali-dation as a result of standard changes
  • Liaising with external test houses to ensure successful testing of the product to required standards

About You:

  • A degree level qualification
  • Demonstrable detailed knowledge of the product approval process
  • Practical experience of ensuring compliance with EN 60601
  • Technical understanding of complex electro-mechanical devices, ideally in a medical environment
  • Knowledge of ISO standards, FDA, MDD, MDR and regulations applicable to the design and development of medical devices
  • A genuine desire to help and support team members so that we can all achieve our best
  • Excellent planning and organisational skills
  • High attention to detail
  • Exceptional communication skills

Job Application:

If you would like to be considered for this role, please apply to send a copy of your full CV – or call us now.

Whilst this position may not be of interest to you or suit your skills and experience, please don’t hesitate to get in contact with a member of the team at Willcox Matthews to understand how we can support you.

We receive a large number of applications for all of our positions – Therefore, if you have not received a response within 10 working days, your application has unfortunately been unsuccessful on this occasion.

Candidates must be eligible to work and live in the UK