Sr Regulatory Affairs Specialist
Confidential
Sylmar, CA
Full-time
Health Care Provider
Posted on June 14, 2020
SR REGULATORY AFFAIRS SPECIALIST: St. Jude Medical in Sylmar, CA seeks qualified Sr Regulatory Affairs (RA) Specialist. Resp for supporting strategy development & approval for product testing protocols, reports & product approval reg strategies under supervision of RA Manager &/or RA Director. Masters or foreign equiv in Pharma, Biomed Eng, Microbio, Biotech, Life Sci, RA/RA Sci or in closely rltd conc (Will accept a Bachelor's degree in the above fields + 5 yrs of rltd progressive exp in lieu of Masters) each alt req w/ an acad or ind background in : (i) Preparing & submitting international product registrations & licensing apps multiple risk class products globally; (ii) ensuring compliance w/ FDA & international reg reqs, incl 21 CFR 820 and ISO:13485; (iii) understanding, investigating & evaluating reg history/background of class, disease/ therapeutic/diagnostic context to assess reg implications for approval, & determine trade issues to anticipate regulatory obstacles; & (iv) providing reg representation & support for design review, design change & design transfer thruout product lifecycle. Emp will accept any suitable combo of edu, training, or exp. An EOE. 40 hrs/wk. Respond by mail: Resumes, St. Jude Medical, Attn: Kathleen Ellwanger, 100 Abbott Park Rd., Bldg. AP6A, Dept. 32RC, Abbott Park, IL 60064. Refer to ad code: SJM-0054-KE.