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Regulatory Specialist

Job Description

Job Description

As a Regulatory Specialist, you will work in a small team on several regulatory activities including Technical File remediation (IVDR) and supporting global product submissions.

Day to day you can expect to:

  • Work closely with the existing staff to lead registrations globally, areas of focus include Korea and Turkey.

  • Provide regulatory support for all post-market surveillance activities.

  • Work closely with the QARA Manager to implement a Risk Management process.

  • Complete technical file remediation for IVDR and MDR compliance.

  • Maintain and approve product labeling to meet regulatory & UDI requirements.

  • Assist with the UKCA marking project.

Candidate Description

You will need 2-3 years of industry experience to be considered for this position and ideally have had exposure working with IVDs.

If this sounds like something you want to be part of and you have the relevant experience, then please apply and I will be in touch to talk in more detail.

Application Description

To speak to a recruitment expert please contact Amy Holder

Employer Description

Adecco is working with a leading medical diagnostic business recruiting a Regulatory Specialist to join the team on a permanent basis.