Senior Regulatory Affairs Lead

L7

meridian bioscienceNorth Billerica, MAyesterday
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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Apply now

Level

ManagerL7

Location

North Billerica, MA

Occupation

Regulatory Affairs Managers

Industry

Research and Development in Biotechnology (except Nanobiotechnology)

Posted

yesterday

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