CER Writer

CER Writer
  • £30,000 per Annum
    ANNUM
  • Permanent
  • Ripon, North Yorkshire, England, UK Ripon North Yorkshire UK HG4 1NS
Job Ref: J2163256
Sector: Engineering
Sub-sectors: Biotech/Life Sciences, Medical Devices
Date Added: 10 January 2022
An established, global medical device compnay is looking for a Clinical Evaluation Report Writer to join their site in Ripon. Majority remote working.

Here at SRG, we partner with an established, global medical device company with a wide-ranging product portfolio. They are looking for someone with technical or scientific writing experience to join their brand as a Clinical Evaluation Report (CER) Writer.

As a CER Writer, you will be working on a variety of different devices and liaising with many cross-functional departments as well as internal and external stakeholders. Some of your key duties and responsibilities include, but are not limited to, the following:

  • Conduct scientific literature reviews and compile reports, such as annual literature updates and periodic safety updates, to provide to global regulatory agencies
  • Generate protocols and reports using a well-defined scientific/research methodology
  • 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 products
  • Write Post Market Surveillance Plans and reports
  • Update Instructions for use, Risk Assessments following clinical review
  • Collaborate with team on responses to questions / requests for more information from reviewers and auditors regarding these documents

This role is remote but requires occasional visits to the Ripon site.

As the ideal candidate, you will have a degree or above in a relevant discipline (BS or above in Biology, Chemistry, Biomedical Engineering, or related field). You will have experience conducting systematic reviews for medical devices, have technical / scientific writing experience and you will have had experience or involvement to CER compliant with MEDDEV 2.7/1 rev 4. It is essential you have experience with MDD and beneficial if you have experience with MDR. It is key that you are self-motivated with great time management skills as well as interpret and review clinical results.

SRGTalent
09/02/2022 13:47:37
GBP 30000.00 30000.00 Annum

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