Perform Clinical Evaluations and write/update Clinical Evaluation Reports (CERs) and Clinical Evaluation Plans (CEPs)  in compliance with the European Union (EU) Medical Device Regulation (MDR).  Perform Literature Reviews using PubMed, Embase, Cochrane Library, and similar databases. Interpret the current, new, and changing requirements for clinical research—including heightened restrictions on product equivalency—to ensure the proper clinical information about the device is available for use within the company.  Contribute to successful transfers of research results into the MDR-compliant CER.

• Work with all interested parties to ensure that the clinical evaluation (per MDR) is conducted including clinical testing of all indications/changes in a timely manner to meet feasibility goals and all regulatory deadlines.
• Ensure sites provide adequate ongoing clinical recruitment and submission of data to client and provide tabular data to regulatory as the basis of clinical reports.
• Support scientific abstract submission and use clinical data as the basis for preparation of presentations.
• Advise colleagues in R&D department on new technical and clinical developments.
• Work closely with cross-functional teams to interpret device performance information in clinical settings and in patient use.
• Perform research as needed to provide applicable information about new technology in Diagnostic Imaging
• Participate in Human Factors / Usability Testing by 3rd party providers, develop protocols, train engineers, and observe testing
• Identify issues that need resolution to ensure safety and effectiveness of the products.

• Coordinate, prepare, and execute premarket applications to the US FDA including Premarket Notification [510(k)], Pre-Sub, IDE, PMA, and De Novo submissions in a timely manner. Act as liaison with FDA regarding product submissions.
• Assess necessity for submitting a 510(k) application for proposed device modifications. Prepare robust non-filing justifications for changes that do not require a 510(k) submission.
• Coordinate and prepare technical files for submission to European Notified Bodies for timely CE marking of new and modified products, with appropriate input from supporting functions (R&D, Quality, Manufacturing, Medical Affairs, etc.).
• Represent Clinical Affairs and demonstrate leadership in complex product development teams by identifying and interpreting relevant clinical regulatory requirements and providing actionable regulatory guidance throughout the product development cycle prior to regulatory submission.
• Identify and communicate appropriately quantified risks and mitigation approaches associated with regulatory strategies to stakeholders.
• Lead clinical evaluation efforts required to comply with new regulations (e.g., EU MDR/IVDR, MDSAP) and other requirements including changes to international standards.
• Review and approve product labeling, promotional materials, and advertising materials to ensure consistency with the Clinical Evaluation Report.
• Review clinical and human factors protocols/reports to assure collection of appropriate data for regulatory submissions and regulatory compliance. Engage with Medical Affairs in the development and approval of Clinical Evaluation Report to assure the documents meet regulatory requirements.
• Ensures FDA device listings and facility registrations are maintained.
• Develop and maintain standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards.
• Coordinate and respond to requests for product information, and questionnaires requested by customers.
• Remain current on regulations affecting medical device products (EU MDR/IVDR, reclassification activities, etc.) and keep the relevant team and supervisors informed about potential impact.
• Identify ways to improve the efficiency of current work process and execute them.
• Carry out the above tasks without supervision.
• Strong organizational skills, ability to work on multiple projects, and work effectively in a demanding, time-sensitive environment
• Interest in and passion for research, bringing medical innovations to market and working in multidisciplinary teams
• Good communication skills, written and verbal
• Available to travel domestically approximately 25%, with occasional international travel.