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 #02767 About our client Our client is one of the world's leading medical device providers. They are a highly profitable, publicly traded company whose products are currently being sold in over 120 countries worldwide. This is a great opportunity for someone to join a company, which offers a great corporate culture and is focused on the long-term development of its employees. Position Location Regulatory Affairs Representative North California Salary Highly competitive package, commensurate with experience Responsibilities 1) Ensure that existing approvals and documents are maintained as per company policies and procedures 2) Provide guidance in establishing reviews for protocols and reports for design verification and validation 3) Participate in design reviews of products under development 4) Oversee product release approval 5) Prepare complex submissions to gain global approvals for clinical research, export and commercial distribution (IDE, 510(k), PMA, Shonin, Design Dossier, etc.) 6) Develop and maintain a positive relationships with the regulatory agencies through oral and written communications 7) Communicate with regulatory agencies regarding pre-submissions strategies, potential regulatory pathways, compliance test requirements, etc. 8) Follow-up submissions under review 9) Ensure regulatory compliance through appropriate filings, documentation, product approval and registration as well as recall as required by the FDA and other authorities Requirements 1) Bachelor's degree (BA/BS) or higher in a related field 2) Up to 2 years of regulatory experience in medical devices 3) 2 – 5 years of experience in a FDA-regulated industry 4) Experience in legal, technical or medically-related area preferred 5) Ability to understand and explain detailed regulatory compliance programs and/or issues 6) Proficiency in (or the ability to learn) MS Office and other related software 7) Ability to review printed material and use common office equipment 8) Superb analytical and writing skills 9) Excellent interpersonal and organizational skills 10) Self-motivated with good judgment 11) Ability to lift, carry as well as exert 10lbs of force (occasionally)
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