CER Specialist

  • Location
    Sheffield, South Yorkshire
  • Salary
    £ 45000 - £ 50000 / Year
  • Job type
  • Industry
    Manufacturing and Production
  • External Reference
  • Category
    Industrial & Manufacturing and Production - Manufacturing

Adecco Lifesciences are working with a long-standing and highly successful Medical Device manufacturer who is looking for a Clinical Specialist to join the team on a permanent basis.

This role would see you research clinical, scientific, and technical literature whilst being responsible for authoring new requirements and maintaining previous clinical evaluation reports (CERs), and Risk Management documentation.

You will play a key role in supporting the Compliance team to ensure re-certification of design dossiers and you will contribute clinical and scientific content to the Design History File.

You can expect to:

Conduct scientific literature reviews and compile reports, such as annual literature updates and periodic safety updates, to provide to global regulatory agencies.

Write and contribute to Clinical Evaluation Plans, Clinical Evaluation Reports, Post Market Clinical Follow-Up Plans and Reports, and Summaries of Safety and Clinical Performance supporting multiple medical devices to facilitate design dossier/DHF submissions and meet ISO 14155.

Update Instructions For Use and Risk Assessments following clinical review.

Conduct ad hoc literature reviews and data synthesis as required for substantiating product claims and supporting CER's.

Analyse and interpret several complex sources of Clinical Data and literature searches.

Ensure CERs comply with MEDDEV 2.7/1 rev 4 to meet ISO 14155 and MDR Annex XIV.

Ensure re-submissions remain compliant with the latest developments in ISO 13485.

Design set up and manage clinical studies in compliance with protocols and the applicable regulations and standards.

The business strives to offer each candidate continuous professional development and education allowing you to gain further knowledge in the field of clinical science.
If you are adaptable, productive and someone who loves to achieve goals, you will thrive in this role.

To be considered you must have:

Previous industry experience within Medical Devices, analysing and summarising clinical data.
Orthopedic or Class iii implantable exposure.
Written CER's and led or prepared for clinical studies.

If this role seems of interest and you have the relevant experience, then please apply and I will be in touch to talk in more detail.

Adecco Lifesciences is acting as an Employment Agency in relation to this vacancy.

To speak to a recruitment expert please contact Amy Holder