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 #02768 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 Senior Regulatory Affairs Representative North California Salary Highly competitive package, commensurate with experience Responsibilities 1) Ensure regulatory compliance through appropriate filings, documentation, product approval, registration and recall (as required) by the FDA and other competent authorities 2) Provide guidance in establishing reviews for protocols and reports for design verification and validation 3) Ensure that existing approvals and documents are maintained in accordance with company’s policies and procedures 4) Conduct design reviews, product release and regulatory action assessment 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 positive relationships with 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 Requirements 1) Bachelor's degree (BS/BA) or higher in a related field 2) 2 – 5 years of experience in an FDA-regulated industry (RAC designation a plus) 3) Experience in legal, technical or medically-related area preferred 4) Experience in medical devices 5) Ability to understand and explain detailed regulatory compliance programs and/or issues 6) Proficiency in (or ability to learn) MS Office and other related software 7) Ability to review printed material and use common office equipment 8) Excellent interpersonal and organizational skills 9) Ability to exert up to 10 pounds of force (occasionally) and/or negligible force to lift, carry, etc. 10) Superb analytical and writing skills 11) Self-motivated with good judgment
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