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.
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