Analyst, Product Surveillance

Title: Analyst, Product SurveillanceLocation: Minnetonka, MNDuration: 12 Months100% OnsiteMain Purpose of the Role Analyzes customer complaints to determine which are regulatory reportable and coordinates activities with internal, field, and end use customers. Responsible for adherence to Good Manufacturing Practices (GMPs) and proper complaint handling per the Code of Federal Register (CFR) and other governmental regulations. Communicates event investigation results via regulatory reports and written communications, as appropriate.Main Responsibilities Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.Participate in development and modification of these decision models with changes in product advances/therapies to uphold consistent compliance with government-mandated regulations.Evaluate and investigate identified complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.Collect, compile, and document regulatory reportability decisions using event investigation and regulatory decision models.Draft Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities.Apply codes to events to facilitate product performance records.Review coding and investigations with engineering, laboratory, and other internal staff.Draft written communications detailing the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to physician and other end use customers.Communications include determination/eligibility for warranty credit or unreimbursed medical payments.Begins establishing and cultivating a network of internal resources to facilitate completion of tasks.Individual influence is typically exerted at the peer level.Completes daily work to meet established schedule with guidance from supervisor on prioritization of tasks.May exercise authority within pre-established limits and approval.Failure to achieve results can normally be overcome without serious effect on the business.Consultants Eligible Benefits Upon Waiting Period Medical and Prescription Drug PlansDental PlanVision PlanHealth Savings Account (for High-Deductible Health Plans)Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)Supplemental Life InsuranceShort Term Disability (coverage varies by state)Long Term DisabilityCritical Illness, Hospital coverage, Accident InsuranceMetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance401(k)#J-18808-Ljbffr

Government Careers

Show more