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Regulatory Affairs Manager

Employer
Amgen
Location
Thousand Oaks, California
Salary
Not Specified
Closing date
Dec 18, 2016

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Sector
Pharmaceutical, Regulatory Affairs
Organization Type
Corporate

Regulatory Affairs Manager sought by Amgen. Reqs: Master’s degree + 3 yrs exp; and Regulatory SW exp w/ mobile apps, stand-alone SW, & imbedded SW; Exp in Regulatory Affairs [eg. 510(k)/PMA filings]; Application of device qty mgmt sys, labeling, human factors, design verification/validation, reqs in SW (stand-alone and imbedded); Previous medical device submission exp in regards to SW as a medical device;  and Knwldg of how risk is mitigated w/ SW. Job Site: Thousand Oaks, CA.  Send resume w/ ref #A38LRJ to: Global Mobility, Amgen, Inc., One Amgen Center Drive, Mailstop B-21-2-A, Thousand Oaks, CA  91320.  No phone calls or e-mails please.  Must be legally authorized to work in the U.S. w/o sponsorship.  EOE. 

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