Knowledge of Clinical Evaluation Reports (CER) as per EU MDR, MEDDEV 2.7/1 Rev 4.
Perform the risk benefit analysis as per ISO 14971 to demonstrate the medical device benefits outweighed the residual risk.
Writes and contributes to Clinical Evaluation reporting deliverables including Clinical Evaluation Plans/Reports, PMS and PMCF Plans/Reports, SSCPs, Regulatory Responses and other related documentation.
Literature reviews, Appraisal of literature article for data suitability and data contribution, Writing literature summary.
Knowledge of Clinical Evidence Summaries & Summarizing and analyzing data from clinical studies.
Consulting, Editing statistical and clinical reports, review of medical journals and technical reports.
Good knowledge on EU MDR, ISO 14155.
Expertise in writing regulatory documents like Clinical evaluation reports(CER) pertaining to medical devices(end to end) as per MedDev 2.7.1 Rev 4.
How to work on Gap analysis of CER's according to MEDDEV 2.7.1 Rev 4.
Preparing literature search strategy,Screening and summarization by using PubMed,Google Scholar Writing Manuscripts(Research paper, Review articles,abstracts).
Experience in Client Communication and Status Reporting.
Assisting with other clinical, regulatory, quality and projects as assigned.
Responsible for acquiring, interpreting, analyzing and drawing conclusions from clinical data from clinical trials, literature and experiences for a wide variety of medical devices specifically Ophthalmic Products.
Strong knowledge and understanding of Good Clinical Practices and regulatory standards
Qualification:
2- 3 years in clinical, regulatory, quality work experience or1-2 years in CER writing experience with solid knowledge of EU MDR Med Dev 2.7/1, rev 4.
Bachelor Degree or Master's Degree or PhD (preferred) in a scientific discipline.
Able to read, analyze and implement regulations, standards and guidance
Professional clinical research certification (e.g., Association of Clinical Research Professionals, Society of Clinical Research Associates)
Freshers can also apply if they have knowledge of clinical research.
