REGULATORY AFFAIRS (RA) SPECIALIST II: St. Jude Medical, an Abbott Labs Co., seeks qualified RA Specialist II in Sylmar, CA. Perform specialized lvl work assignments &/or analyses, eval, prep & submission of docs for worldwide regulatory registration, ensuring products & procedures comply w/regulatory agency specs. Bachelors or foreign equiv in RA/Science, Sci, Eng or in closely rltd technical fld of study w/ min. 2 yrs of pro med device RA or engineering exp in: (i) applying knowledge of US & EU regulatory requirements & preparing, submitting & maintaining domestic & international technical files, product registrations & licensing applications; (ii) ensuring & coordinating compliance w/ quality mgmt system & risk mgmt regulatory requirements thruout product lifecycle, incl ISO 13485, FDA 21 CFR 820 & EU MDR/MDD; (iii) preparing U.S. regulatory submissions s/a 510(k) applications PMA supplements, EU submissions/technical files &/or other international med device regulations; & (iv) providing regulatory guidance to cross-functional team (product design, manufacturing, packaging, sterilization, biocompatibility & labeling) for new product development & sustaining projects. An EOE. 40 hrs/wk. $65,900 - $131,900/year. Send Resumes to: Abbott Laboratories, Attn: Elvia Salazar, Willis Tower, 233 S. Wacker Drive, Fl. 25, Dept. 32, Chicago, IL 60606. Refer to ad code: SJM-0025-ES.
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