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.
#J-18808-LjbffrSenior Regulatory Affairs Manager – Medical Devices & Biologics in canton at Unknown Company
This position is listed as full time and onsite.