Regulatory Compliance Professional

6 days ago


Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full time

Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our team at Newton Colmore Consulting Ltd. As a Quality Engineer, you will play a critical role in ensuring the quality and safety of our Medical Devices.

Key Responsibilities

  • Collaborate with cross-functional teams, including Mechanical Engineers, Physicists, Electronics Engineers, Software Engineers, and other professionals to ensure quality and compliance.
  • Develop and maintain technical files and testing documentation to meet ISO 13485 standards.
  • Conduct design assurance activities to ensure compliance with regulatory requirements.
  • Work closely with our clients to understand their quality and compliance needs.
  • Provide expert advice on quality and regulatory matters.

Requirements

  • Relevant degree in a field related to Medical Devices or Quality Assurance.
  • Proven experience in Quality Assurance and Regulatory Compliance.
  • Strong knowledge of ISO 13485 and EN 60601 standards.
  • Excellent communication and interpersonal skills.

What We Offer

  • Competitive salary and bonus structure.
  • Generous pension and life assurance scheme.
  • Healthcare and other excellent benefits.


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