Regulatory Affairs Specialist, Medical Devices - (Un-UT-Salt Lake City - 84199)

Minimum Education: Bachelors
Jobcode: 280325
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This position assists with the domestic (U.S.) activities of the Regulatory Affairs department according to corporate procedures and policies; U.S. Government policies, primarily the Food and Drug Administration (FDA); and applicable State requirements.Summary of Position with General Responsibilities:On assignment, implements or oversees the preparation of Investigational Device Exemption (IDE) protocols between BAS Medical Affairs office and product teams, writes an IDE and aids with its implementation. May work with contract research organizations to develop and implement clinical trial protocols. Serves as RA representative on product teams as assigned and signs test protocols and reports as required. Develops and administers new product field trials as required. Coordinates the collection of data and information for regulatory submissions; writes the required regulatory submissions for new BAS products. Review and approve documentation Change Requests and labeling artwork changes per BAS and corporate SOPs. Performs GMP/ISO 9000 audits as requested by Department Head. Performs special projects, such as administering recalls, as required by Department Head. Maintain FDA medical device listing/registration information as requested for BAS and Reynosa. As requested, serves as alternate BAS facility FDA inspection coordinator. Prepares and submits PMA annual report and approve PMA related Change Requests. Serves as the BAS international information contact person, coordinates the preparation of BAS international dossiers with the assigned product teams and updates them as required. Develop and maintain MDR and vigilance reporting paradigm.Basic Qualifications:This position requires a Bachelors Degree in a Life or an Engineering Science plus five or more years US, CE and international regulatory affairs experience. Exposure to GMP/ISO 9000 training is mandatory. The incumbent must have demonstrated communication and human relation skills. Experience with MDR and vigilance reporting determination, or equivalent, is required. Experience representing Regulatory Affairs on a cross functional team is required. Preferred requirements are a Regulatory Affairs Professional Society (RAPS) certification. Experience working in a multi-level corporate environment typical of large corporations.