Sign-up for the Sterling-Hoffman Life Sciences Journal to get the latest industry news and job postings.		To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.  Job #02544 About our client Our client is amongst the top servers of science and serves up to 35,000 customers in varied fields such as pharmaceutical and biotech companies, hospitals and clinical diagnostics labs, industrial process control settings, environmental settings, government agencies and also to universities and research institutes. The company employs over 30,000 people across 150 countries worldwide and provides a total range of high-end equipments, analytical instruments, reagents and consumables. They also provide software and services for research, analysis, discovery and diagnostics. Position Location Regulatory Affairs Manager Northern California Salary Highly competitive package, commensurate with experience Responsibilities 1) Prepare/coordinate regulatory filings in the U.S. and worldwide such as CE Mark/IVDD compliance, submissions to FDA and worldwide agencies of all required registration, licenses and reports and preparing FDA 510(k) 2) Review processes (i.e. customer complaints for compliance) 3) Assess whether corrective and preventative action is required 4) Change control for regulatory assessment, CE Mark IVDD and add-to-file technical files for completeness and accuracy prior to FDA submission Requirements 1) BS/BA in science-related field 2) Minimum 3-5 years of regulatory affairs experience and/or training (or the equivalent combination of education) 3) Experience in the In-Vitro Diagnostics (IVD) 4) Medical device industry a plus 5) RAP certificate preferred 6) Knowledge of basic laboratory and clinical experimental skills a plus 7) Proven ability to write clear, understandable technical documentation (i.e. regulatory documentation or scientific presentations) 8) Ability to follow and give clear, written and verbal directions with a high level of accuracy
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