Company Website: www.Cookmedical.com – Please make sure you review the website and understand their products along with the history of the company.
Job Description: The Medical Reviewer uses clinical knowledge and expertise to provide clinical review of the Clinical Evaluation Report and participates in Post-Market Clinical Follow-up planning activities.
• The Medical Reviewer provides clinical review Clinical Evaluation Report (CER), Clinical Evaluation Plan (CEP), Post-Market Clinical Follow-up (PMCF) Plan, and other risk management documents, as requested
• The Medical Reviewer displays a deep understanding of the medical device life cycle
• The Medical Reviewer has a clinical understanding of the risks, benefits, patient selection, and treatment options for the appropriate disease groups
• The Medical Reviewer utilizes pre-clinical data, risk management assessments, published literature, clinical investigation results, and field performance data in order to evaluate product safety and performance
• The Medical Reviewer provides input and guidance throughout the CER writing process
• The Medical Reviewer participates in the PMCF planning activities
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization
• Must have effective oral and written communication skills
• Must strictly adhere to safety requirements
• Maintain regular and punctual attendance
• Must maintain company quality standards
• MD or DO degree. Clinical experience with direct patient care preferred. Board certification is not required
• Appropriate clinical knowledge and experience required, such as exposure to medical and surgical procedures and the use of medical devices in a clinical setting
• 2-3 years of relevant industry experience preferred
• Exposure to MEDDEV 2.7/1 Rev 4 and EU Medical Device Requirements
• CER and PMCF writing experience preferred
• Experience with literature searches and manuscript or thesis preparation
· Capable technical writing skills
• Knowledge of statistics and their application to the interpretation and
• Strong analytical skills
• Interest and skilled at literature- and web-based research
• Microsoft Office proficiency (Excel, Word, Outlook)
• Proficient in reading, writing and speaking the English language
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• Provides clinical expertise and support to Business Development, Product Development, Engineering, Quality Engineering, Regulatory Affairs, Regulatory Reporting, Marketing, Quality Assurance, and other internal groups
• Performs pre- and postmarket medical device risk management (in compliance with ISO14971), including Health Hazard Evaluation (HHE), Health Risk Assessment (HRA), Clinical Effect Analyses (CEA), Risk-Benefit Analysis (RBA), Hazard Analysis (HA)
• Provides medical review of Clinical Evaluation Reports (CERs)
• Works with cross-functional teams to develop EU MDR procedures
• Assists in development of quality system procedures and instructions
• Performs complaints review and analysis
• Contributes and reviews Failure Mode and Effects Analyses (dFMEA, pFMEA, uFMEA)
• Provides review of Instructions For Use (IFU), marketing and promotional materials, training and educational materials
• Conducts systematic literature searches
• Develops various training materials
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