Staff Clinical Evaluation Specialist

Job description

Work Flexibility: Not available What you will do- Drive the establishment of a coherent Clinical evidence strategy plan throughout the new product development cycle, and ensure alignment with adjacent complex processes (Marketing strategy and claim, regulatory strategy, research strategy) Prepare clinical documentation to validate device safety and performance for regulatory body submissions and perform periodic updates to maintain compliance (e.g CERs, SSCPs, PMA reports). Design compliant and sutainable literature search strategies, perform systematic reviews to capture and summarize published clinical data Formulate conclusion on the overall benefit-risk profile of the subject device, in collaboartion with appropriate stakeholders Identifies unanswered questions and residual risks in the Clinical Evidence and provides input to Post Market Clinical Follow Up activities in collaboration with Clinical Research team to address these questions Reviews clinical evaluation documentation authored by peers, junior, or external contributors for compliance internal and external quality and regulatory requirements Provide clinical input to project plans, pre-IDE and 510(k) and PMA applications by describing user needs, user characteristics, intended use and clinical application of products; advocate the safety of devices for the operator and the patient Particiapte in the development of the safety risk analysis Support the Human Factors team to develop use scenarions and user needs when needed Review product related complaints related to potential adverse events or device malfunctions to determine whether or not the device use contributed to harm Provide input to and participate in post-production Corrective and Preventive Action activities and provide input in the creation of operating instructions (manuals, labeling, quick reference labeling, operator installation/getting started instructions, in-service video and other user instructional or clinically-oriented literature) and evaluate accuracy and adequacy). Provide input to clinical research team on study protocol development and support the conduct of clinical studies as needed and support to marketing and engineering for customer issues Review collateral materials that includes clinical outcome claims and perform other related duties as assigned to support business needs What You will need- Required Skills- A minimum of bachelor's degree in a technical and/or scientific discipline required Experience- 7 years- 10 years A degree in Nursing or related field or related experience in an advanced practice environment such as critical care, critical care transport, emergency room, flight nurse, or military medical training required; Master's or Ph.D or other higher degree in health related field (RN,BSN,MD) preferred Experience in medical device industry is strongly preferred; with Minimum of 4 years industry experience in clinical, quality or regulatory affairs Experience in scientific or medical writing, relevant academic or clinical research experience is preferred Demonstrated ability to read, analyze, and interpret regulations, technical standards, guidance documents, test reports, clinical and medical terminology, Preferred Skills- technical product information, and complex documents and successful track record in managing complex projects Ability to train and mentor junior team members; to own and maintain internal procedures and processes and to effectively present information to other employees and management Good MS Office skills and general IT proficiency Ability to travel up to 20% Travel Percentage: None