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