As Clinical Evaluation Specialist, you will utilise your medical writing, and literature review experience to generate CER, gain product approvals, and ensure continued CE marking for a global medical device organisation.
- Remote working - if desired
- Work on global product registrations, with international stakeholders and innovators
- Pension, Healthcare, Bonus, Competitive Base Salary, Training & Development
- Leads completion of clinical evaluation reports (CERs) for CE registration including guidance to less experienced team members
- Works with internal teams to gain cross-functional inputs and approvals into evidence evaluation documentation activities
- Generates and maintain reference databases
- Support the periodic and ad hoc assessments of device safety and efficacy in support of post-market surveillance and risk management objectives
- Support the registration of products in non-EU countries
- Relevant experience in either an academic or commercial setting
- Proven experience of performing literature reviews, analysing data sets and communicating the outputs
- Experience working within a medical devices or pharmaceutical organisation in a Research & Development, Scientific and Medical Affairs, Clinical or Regulatory role
- Experience in writing scientific documents for regulatory or journal submissions
- Experience in presenting scientific/clinical evidence in a written and oral manner to cross-discipline teams.
- Excellent scientific writing skills
- Strong data extraction and analysis skills
- Good communicator and able to work collaboratively as part of a team
- Self-motivated and able to work independently
- Excellent time management skills and ability to work under pressure to deadlines
- Must exhibit high quality, ethical and compliant work habits
- Experience in reference management software.
For more information, or to discuss your career in the Medical Device arena, please contact Holly Evans on email@example.com
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