FDA Complaints Analyst

Quality Systems, Compliance, FDA/ISO13485, Regulatory Agencies
Contract W2, 6+ months
Negotiable
Telecommuting not available Travel not required

Job Description

Please note that this is a 6+ month contract position.

 

The Complaints Analyst will be responsible for maintaining the quality processes associated with regulatory reporting and its procedures and controls to ensure that all MDR reportable complaints are processed and submitted in accordance with established company procedures and worldwide regulations and standards. This individual will review of reportable and potentially reportable complaints from incoming calls, faxes, and emails from all areas of the world. This individual will also ensure adequate information is received to warrant timely reporting, investigation, and closure of reportable complaints, including sound regulatory reporting decisions/justifications for worldwide reporting. The individual applies standard practices and procedures, adjusts and correlates data, recognizes discrepancies in results, and follows operations through a series of related detailed steps and processes. 

Essential Duties and Responsibilities: 
• Responsible for the complaints regulatory reporting process (timely submissions, closure, health authority requests etc.) 
• Responsible for ensuring all required information for a complaint file is obtained and properly documented to make sound regulatory reporting decisions. 
• Evaluates all information from a clinical and technical perspective to ensure appropriate Analysis, Investigation, Root Cause, and Quality Engineering review is documented prior to complaint closure. 
• Set up complaint meetings and effectively communicate with worldwide complaint groups, as well as other internal departments such as Marketing, R&D, Customer Service and Technical Services. 
• Understands basic principles, theories, concepts and techniques related to customer complaints. 
• Escalate critical issues for proper disposition as necessary. 
Other Assignments: 

• May receive technical guidance on complex problems, but independently determines and develops approaches and solutions. Work is expected to result in the development of new or improved techniques or procedures 
• Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, CMDCAS, PMDA and other worldwide regulatory agencies,  Environmental, Health & Safety Practices, and other applicable standards as pertains to medical devices. 
• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance. 
• Support Product Analysis Evaluation if required 
• Performs other duties assigned as needed

 

For consideration, please reference job number 2205.

Posted By

San Francisco, CA

Contact
Dice Id : NETSO
Position Id : 2205
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