Salesforce Administrator
Company: Confidential
Location: Beverly Hills
Posted on: October 22, 2024
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Job Description:
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.
recblid d949t6iejs62me4myktw453hkgs77y
Keywords: Confidential, Torrance , Salesforce Administrator, Other , Beverly Hills, California
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