MDR Regulatory Reporting Specialist
Medline Industries Holdings LP
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Job summary
Medline Industries, LP is seeking a Regulatory Reporting Specialist to evaluate product complaints for MDR reportability and prepare submissions via FDA’s eMDR, ensuring compliance with 21 CFR 803 and related Quality System requirements. The role collaborates across Quality, Regulatory Affairs, R&D, and Operations to gather data and make accurate regulatory determinations.
Requirements include a Bachelor’s degree in a relevant field and 1+ year of experience in complaint handling, MDR
Job description
Medline Industries, LP is seeking a Regulatory Reporting Specialist to evaluate product complaints for MDR reportability and prepare submissions via FDA’s eMDR, ensuring compliance with 21 CFR 803 and related Quality System requirements. The role collaborates across Quality, Regulatory Affairs, R&D, and Operations to gather data and make accurate regulatory determinations.
Requirements include a Bachelor’s degree in a relevant field and 1+ year of experience in complaint handling, MDR
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