This is an opportunity to join a global medical devices organization that have been patient-focused for over two decades in the manufacturing of their 1000s of orthopedic products. Fully remote and part of the experienced medical writing team, you'll be able to drive the strategy and overall completion of the CERs under MEDDEV 2.7/1 rev4.
- Perform systematic literature searches and reviews for clinical regulatory document creation. Interpret and synthesize literature information for use in clinical regulatory documents.
- Compile clinical evidence from multiple sources such as current and past clinical trials, post market clinical follow up data and literature review updates, ad-hoc analysis, meta analyses, or other sources of safety and performance data
- Write, edit, and proofread Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF) plans and evaluation reports, Summary of Safety and Clinical Performance (SSCP), Post-market Surveillance (PMS) plans, Post-market Surveillance reports (PMSRs), and Periodic Safety Update reports (PSURs)
- Work in a cross-functional team to establish clinical study protocols and reports, data summaries from raw data and document strategies.
- Review clinical protocols to ensure collection of data is sufficient for regulatory submissions.
- 5 years' experience within the Medical Devices industry under 21 CFR 820 or ISO:13485 regulations.
- 2 years' experience writing Clinical Evaluation Reports (CERs) for Medical Device products in accordance with EU MDR.
We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.