Experience must include two 2 years of postbachelors progressive experience in all of the following Strategy development for US Class III Medical Device PMA PreMarket Approval; MDD Medical Device Directive design dossiers, technical files and change notifications; Premarket clinical investigations for Class III and Class II medical devices; Total product lifecycle regulatory experience to include preclinical, clinical, approval, postapproval and obsolescence; Food Drug and Cosmetic Act and relevant Medical Device Regulations to include 21 CFR Parts 11, 807,812,814, 820; Medical Device Quality Systems to include ISO13485 and ISO14971.

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