Associate MDR/Vigilance Specialist (W2 Only)

***W2 ONLY, C2C candidates, or Candidates with the following Visa Status will not be accepted: H1B, OPT, OPT-STEM**Associate MDR/Vigilance Specialist (Through February 2027 // Mounds View, MN): Manager Note: Onsite 4 days/week, remote 1 day/week9 months approval through go-live date of new complaints system in FebruaryLikely extension due to potential project delays with system deploymentTop Needs:Nursing/medical backgrounds (ideally with clinical experience working with medical devices)Complaint handling or AE/SAE experience ideal (not required) or Customer Service experienceAnalytical thinking skills Education Required: BSNYears’ Experience Required: 1+ year in Health Care, Quality, Medical device exposure preferredDuties:Receive and assess product comments to determine need for complaint handling record.Document required information in Global Complaint Handling (GCH).Assess complaint file for missing required information. If information is missing, initiate attempts to gather information. Steps may include contacting: Client Field Personnel Health Care ProvidersPatients or other initial reportersCommunicate with outside parties in a professional and customer-focused manner that is in following with our Mission and enhances the brand.Evaluate incoming product events to determine MDR and Vigilance reporting eligibility.Initiate and complete regulatory reports for timely submission to FDA and other regulatory bodies.Determine if investigation is necessary. If investigation is necessary, determine:Potential cause and contributing factors to the alleged event.Device relationship.If formal device investigation is necessary.Summarize the results of any investigation.Escalate complex issues to management.Execute other projects as assigned.Must Have: Bachelor degree, ideally in Nursing, Biomedical Engineer or other scientific focusHigh level of computer proficiency (e.g. Microsoft Office, SAP, Siebel, Oracle Clinical, etc.)1+ years experience in healthcare or medical device/pharmaceutical industry in safety or clinical data evaluationStrong verbal and written communication skillsKnowledge of basic anatomy and physiologyStrong attention to detailHigh level of computer proficiencyNice to Have:Medical device industry experienceComplaint handling experience