Compliance Specialist

Onsite in Minnetonka - possible 1 day WFHKey ResponsibilitiesReview, assess, and document product complaints and adverse events for marketed productsDetermine event classification, seriousness, reportability, and potential causalityPrepare and submit regulatory reports (e.g., FDA MDR and international regulatory submissions) within required timelinesEnsure compliance with applicable regulations (e.g., 21 CFR Part 803, 21 CFR Part 820, complaint handling requirements)Collaborate cross-functionally to support investigations and resolution of product-related issuesMaintain accurate documentation and support audit readinessManage multiple tasks while maintaining strong attention to detailQualifications3–5 years of experience in post-market surveillance, complaint handling, or medical device/pharmaceutical regulatory environment (flexible for strong junior candidates)Experience with Medical Device Reporting (MDR), including U.S. and international (e.g., EU, OUS) reporting preferredWorking knowledge of medical device regulations and complaint file requirementsStrong organizational, analytical, and communication skillsAbility to work both independently and collaborativelyEducationBachelor's degree in a scientific or healthcare-related field preferredAssociate degree with relevant experience also considered#J-18808-Ljbffr