Medical Device Certification Expert

15 hours ago


Ellesmere Port, Cheshire, United Kingdom SGS Full time
Career Development Opportunity

SGS is seeking a Medical Device Certification Expert to join our team. This is a unique opportunity for experienced professionals looking to specialize in medical device certification.

About the Role

The successful candidate will be responsible for conducting audits at clients' sites and remotely, following established procedures, and maintaining a high standard of service delivery that ensures effective customer relationships.

The ideal candidate will have previous auditing experience within an IVD or IVDR notified body, with a minimum of 4 years 'hands-on' professional experience in designing, manufacturing, or testing of IVDs. They should also have knowledge of EU IVDR 2017/746 and standards relevant to in-vitro diagnostic medical devices.

The estimated salary for this role is $125,000 - $160,000 per annum, depending on experience. We offer a remote working environment and opportunities for international travel.

Key Responsibilities
  1. Support the development of the global SGS medical device auditor network by aiding the qualification of trainee auditors.
  2. Act as a key point of contact for SGS medical device offices, mentor junior colleagues, and help coordinate the expansion of the IVDR auditor network.
  3. Contribute to the continuous improvement of processes and tools used across the SGS network to conduct IVDR conformity assessment.
  4. Work alone or lead audit teams as appropriate, enhance client satisfaction, and ensure compliance with standards and regulatory requirements.


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