Job Description
HM's Top 3:
- This individual should have 2- 5 years or close to that experience authoring/executing Clinical Evaluation Reports, Clinical Evaluation Plans, and PMCF Plan or Reports.
- Must have MDR experience with Clinical Evaluation Report writing experience
- High degree of project management, excellent communication, and initiative. Experience with ReadCube is nice to have.
Education Required: Bachelor's degree required; Strongly preferred to have Masters or PhD degree(s) in biomedical sciences or technical disciplines Years’ Experience Required: Minimum of 4 years medical or clinical writing experience which includes (2 years scientific writing for EU MDR, this includes Clinical Evaluation Reports (CERs) Clinical Evaluation Plans (CEPs), PMCF Plans, and or reports). This role predominantly focuses on writing editing and maintaining Clinical Evaluation Plans and Reports CEP CER and Post Market Follow-up PMCF Plans and Report and Periodic Safety Update Reports PSUR. and responses to Notified Bodies.
- Conducts comprehensive literature searches and performs critical evaluation of clinical evidence including risk/benefit State of the Art etc. for generation of new/maintenance of existing Clinical Evaluation Reports CERs in compliance with the EU Medical Device Regulation Australia Dept of Health Guidelines and other geographic regulations as required or to support product development risk analysis regulatory submissions or due diligence efforts.
- Assesses on an ongoing basis the quality scientific validity and audit-readiness of CERs.
- Supports internal and regulatory body audits of clinical materials including remediation of content as required.
- Analyzes clinical evidence of all kinds e.g. public proprietary published unpublished from all sources e.g. journals internal documents regulatory submissions to assist project proposals and departmental strategies understanding the levels of evidence required to achieve Regulatory Marketing and other departmental goals
Job Tags
Remote job, Contract work,