MDR/Vigilance Specialist

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Position Responsibilities: - Electronically process events to determine complaint and reportability status. Complete applicable Medical Device Reports (MDR) as required per internal policy & procedures and FDA regulations. - Ensure complaint investigations are adequate, accurate, detailed and timely. - Perform tasks to obtain adequate information to ensure proper documentation and closure of each complaint. - Collaborate with appropriate technical, Clinical, Field/Sales and/or returned product analysis employees to determine reporting eligibility. - Complete electronic submission of MDRs to the FDA. - Ensure accurate data entry, scanning, and retention of documents to complete event files. - Support internal systems, methods, and procedures to maintain compliance. - Develop and maintain product knowledge of CRHF products. - Assist in inspection support for FDA and global regulatory agencies. This may include research and preparation of correspondence in response to global regulatory agencies requests for additional information. - Develop and maintain a working knowledge of regulations and standards related to post-market quality & complaint handling. - Complete projects as assigned and required specific to post-market quality and complaint handling. Basic Qualification : Education Required: Bachelor's Degree Years Of Experience: Less than one year experience in a health, clinical, technical, or scientific field with a Bachelor's Degree If you want to apply and want to know more, please contact: Sagar Rathore sagar.rathore(AT)collabera.com 630-485-2166

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Company Intel

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