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Job Field: Legal Jobs
Location: SOUTH JORDAN, UT
Job Type: Full Time

JOB SUMMARY:

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Regulatory Specialist I-Endotek Requisition # 570-4302 This position is responsible to coordinate and help prepare document packages for regulatory submissions, internal audits, governmental inspections, recalls, Medical Device Reports and clinical trials. ESSENTIAL FUNCTIONS PERFORMED ? Coordinates and prepares document packages for: ? Regulatory submissions (domestic and international) ? Facilitates corrective actions on internal audits ? Governmental inspections ? Recalls ? Medical Device Reports ? Clinical trials ? Company policies and procedures ? Interacts, as directed, with various levels of management, external agencies and companies. ? Participates on project task teams. ? Performs other related duties and tasks, as required. ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS ? Lifting -- up to 50 lbs ? Writing ? Sitting ? Standing ? Bending ? Vision ? Color perception ? Depth perception ? Reading ? Field of vision/peripheral ? Fine motor skills SUMMARY OF MINIMUM QUALIFICATIONS ? Education and experience equivalent to a Bachelor's Degree and two years of related experience or seven years of regulatory experience. ? Demonstrated knowledge of regulatory affairs. ? Demonstrated human relations and effective communication skills. ? Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs. ? Strong organizational skills and the ability to be self-motivated and be detailed oriented. COMPETENCIES ? Document packaging and coordination for: ? Regulatory submissions (domestic and international) ? Facilitates corrective actions on internal audits ? Governmental inspections ? Recalls ? Medical Device Reports ? Clinical trials ? Company policies and procedures ? Management/external agency/company interaction. ? Project task team participation

KEY REQUIREMENTS:

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High School Diploma