Organogenesis seeks an experienced regulatory affairs professional to manage regulatory requirements for medical devices and biologics, including HCT/Ps. You will develop regulatory strategies and submissions for FDA and international bodies, and guide product changes for US marketed products. Role requires collaboration with development, manufacturing and quality teams, evaluation of changes for filing requirements, and strong knowledge of FDA, EU, and ICH regulations.

Also on the board Same function, level within a rung

Level

Manager

Location

Canton, MA

Occupation

Regulatory Affairs Managers

Industry

Electromedical and Electrotherapeutic Apparatus Manufacturing

Posted

yesterday

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