Compliance Specialist
GForce Life Sciences, Minnetonka, MN, United States
Onsite in Minnetonka - possible 1 day WFH
Key Responsibilities
Review, assess, and document product complaints and adverse events for marketed products
Determine event classification, seriousness, reportability, and potential causality
Prepare and submit regulatory reports (e.g., FDA MDR and international regulatory submissions) within required timelines
Ensure 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 issues
Maintain accurate documentation and support audit readiness
Manage multiple tasks while maintaining strong attention to detail
Qualifications
3–5 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 preferred
Working knowledge of medical device regulations and complaint file requirements
Strong organizational, analytical, and communication skills
Ability to work both independently and collaboratively
Education
Bachelor’s degree in a scientific or healthcare-related field preferred
Associate degree with relevant experience also considered
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Key Responsibilities
Review, assess, and document product complaints and adverse events for marketed products
Determine event classification, seriousness, reportability, and potential causality
Prepare and submit regulatory reports (e.g., FDA MDR and international regulatory submissions) within required timelines
Ensure 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 issues
Maintain accurate documentation and support audit readiness
Manage multiple tasks while maintaining strong attention to detail
Qualifications
3–5 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 preferred
Working knowledge of medical device regulations and complaint file requirements
Strong organizational, analytical, and communication skills
Ability to work both independently and collaboratively
Education
Bachelor’s degree in a scientific or healthcare-related field preferred
Associate degree with relevant experience also considered
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