Oferta de trabajo: Senior Clinical Affairs Specialist

Collaborate with regulatory on all phases of regulatory submissions, including clinical documentation preparation and review, regulatory document review and the formulation of responses to regulatory agencies. Prepare and maintain Clinical Evaluation Reports, literature sections of Periodic Safety Update Reports and other clinical documentation for Technical Documentation File to support CE mark and other Regulatory documents. Collaborate with R&D, quality assurance, regulatory and marketing teams on clinical study reports, clinical evidence gap assessments, marketing brochures, post-market surveillance reports, risk management documents and other documents that require the evaluation of clinical data and/or clinical literature. Administration of the applicable databases for the activities related to the evaluation of clinical data, Clinical Evaluation reports and Post Market surveillance reporting. Support product safety evaluation and reporting (e.g., MDR/Vigilance) as mandated by country regulations. Maintain regulatory files and track databases as necessary. Assist with creation and implementation of Clinical training including cross-functional learning of regulation expectations. Develop and maintain in-depth knowledge of clinical research best practices, including the planning, execution, and documentation of clinical trials, related Standard Operating Procedures (SOPs), International Standards Organization (ISO) guidelines and regulatory agencies' guidelines on clinical research conduct. Support clinical trial management including the planning and preparation of submissions for clinical studies. Work with regulatory agency audits including FDA (Food and Drug Administration).

Requires Master's degree in Regulatory Affairs and Quality Assurance, Project Management or related field and background in clinical/medical/scientific/regulatory writing; understanding of new product development teams and product lifecycle management; familiarity with implementing regulatory requirements for clinical investigations; familiarity with regulatory agency audits including FDA (Food and Drug Administration); background in direct interaction with regulatory agencies such as the IRB and FDA. Worksite Location: 630 S. Komas Drive, Suite 200, Salt Lake City, UT 84108 and Home Office (a few times per week depending on workload).