Senior Regulatory Affairs Lead
meridian bioscienceNorth Billerica, MA
Senior Regulatory Affairs Lead
meridian bioscienceNorth Billerica, MA
today
Industries
Research and Development in Biotechnology (except Nanobiotechnology)Biological Product (except Diagnostic) ManufacturingElectromedical and Electrotherapeutic Apparatus ManufacturingAbout the role
Meridian Bioscience Inc. is seeking a Regulatory Affairs professional to support released products, manage MDR investigations, post market risk assessments, and maintain technical files for CE marking.
The role liaises with QA, manufacturing, R&D, and customers to coordinate complaint investigations and CAPAs. Responsibilities include updating technical files for FDA and EU submissions, evaluating regulatory impact of design changes, and guiding labeling activities to ensure compliance.
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JOB OVERVIEW
Experience level
Manager
Location
North Billerica, MA
Occupation
Regulatory Affairs Managers
Industry
Research and Development in Biotechnology (except Nanobiotechnology)
Posted
today
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