Position Title: Clinical Evaluation Specialist
Reports to: Management Representative
Main Purpose & Key Accountabilities:
- A highly dynamic role in which you will work to help develop clinical strategies for gastroenterology medical devices by creating clinical documentation that systematically synthesizes information from multiple data sources. As a Clinical Evaluation specialist, you will plan and develop clinical evaluation reports (CERs) and post-market clinical follow-up (PMCF) reports, as well as a summary of safety and clinical performance reports (SSCPs) in alignment with applicable clinical and regulatory standards and business needs. This role applies analytical thought processes and a highly methodical clinical evaluation approach to developing benefit/risk profiles for the Medorah Meditek portfolio of gastroenterology devices and endoscopic accessories. A successful candidate has excellent writing skills as well as the ability to work collaboratively with cross-functional partners.
- Compile, appraise and evaluate data from multiple sources including clinical trials, medical literature, design verification/validation data, and product complaint data.
- Development of literature search strategies and methodical evaluation of medical literature.
- Create analyses to evaluate product benefit/risk profile and safety and performance and develop a profile of adverse events.
- Identify potential clinical evidence gaps and contribute to the development of prospective evidence strategy to address gaps.
- Collaborate with leadership and cross-functional partners to develop global clinical strategies for new product development and/or EU MDR certification, ensure alignment of clinical data with risk documentation, and contribute to product labeling.
- Aid in the development and execution of strategies for regulatory responses for regulatory submissions
- Bachelors/Master’s degree or Advanced degree (Ph.D., research-based MS, MD, RN/DVM) and 3 years of professional experience with Analytical skills, including strong familiarity with medical literature.
- Strong medical/scientific writing skills
- Medical device experience, including an understanding of regulatory ability to understand engineering documentation, including risk documentation