We are an IIP Gold Employer of the Year award-winning medical device company that specialises in the design and manufacture of innovative textile-based implantable medical devices.
We currently have two vacancies for Clinical Evaluation Writers - one permanent and one fixed term for 12 months
Clinical Evidence Manager
- Write and update Clinical Evaluation Reports for new and existing products in accordance with the Medical Device Regulations to assess safety and efficacy.
- Plan and carry out literature searches to identify the state of the art and relevant clinical data on new and existing products.
- Evaluation of Post Market Surveillance (PMS) data, including output from literature searches, complaints data and user feedback. Use this data to assess the safety and performance of devices and prepare PMS Evaluation reports.
- Contribute to the Post Market Surveillance and Post Market Clinical Follow Up Plans, based on data collected in the Clinical Evaluation and PMS evaluations.
- Follow through the actions from PMS activities to ensure relevant documents including Risk Management files, Clinical Evaluation Reports and IFUs are updated as necessary.
Essential Experience, Skills and Qualifications
- Degree in a science or engineering discipline.
- Strong background in conducting literature searches and authoring critical reviews.
- Familiarity with ISO 13485 and the Medical Device Directive / Regulations.
- Experience in the field of clinical research or medical devices preferably within orthopaedics.
Desirable Experience, Skills and Qualifications
- Experience of writing clinical evaluations and undertaking PMS activities.
- Post graduate qualifications in science or engineering.
- Project or Programme Management qualifications/training.
- Experience of working on clinical studies.
Essential Skills and Behaviours
- Excellent interpersonal skills and the ability to work as part of a team across the company.
- Excellent written communication and presentation skills.
- Good organisation and leadership skills and attention to detail.
- A can-do attitude with the ability to take initiative.
- Self-motivated with personal commitment to the role and to providing a high-quality service.
There are two positions available:
one permanent and one fixed term for 12 months
Salary: £34,000 to £38,250
Closing date: Thursday 2nd January 2020
To apply for this role please send your CV and covering letter directly to email@example.com
Please note we will not consider unsolicited CVs from agencies.