Regulatory Affairs Associate job – Professional Partners Group – Chandler, AZ

Regulatory Affairs Associate

Professional Partners Group

Chandler, AZ

Job DescriptionJob Summary: Position supports the preparation of regulatory submissions based on specific project timelines and requests to the support the business. Essential Functions: Support and preparation of regulatory submissions Ensure legalization of submission documentation follows various country requirements. Prepare reports and documents to support international regulatory submissions Preparation of documents and support of activities with Notified Bodies Responsible for maintenance of product technical files Responsible for compliance with European and other directives (CMDCAS, etc.) and regulations Regulatory support activities Assist in activities to maintain and expand CE mark labeling Prepare post-approval reports globally Maintenance of establishment registrations and listings Support clinical affairs registration of clinical studies on Clinicaltrials.gov Prepare documents for global registration dossier and upload to storage location for use by others Required SkillsSkills/Qualifications/Competencies: BS / BA in degree in life sciences or physical sciences Basic working knowledge of FDA labeling regulations, Quality System Regulations, Medical Device Directive and Canadian medical device regulations 1 years of experience in US and international regulatory approval process in medical devices or equivalent level of regulatory experience is desirable Other experience in a medical device company is desirable Previous experience with regulatory submissions including IDE and 510(k) submissions for Class II medical devices is desirable

Professional Partners Group is a leader in the recruiting and staffing world. Our team has more than 25 years in the industry and specialize…

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A Computer Programmer whose articles got mentions from the likes of The New York Times, Kissmetrics and AllTopStories. He writes articles, novels and poems; spends most of his time reading everything he could get his hands on. He is currently pursuing his Masters from The University of Illinois and holds a Bachelors in Electronics Engineering from the University of California. He is a programmer, a motivational writer and speaker.

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