Customer Complaints Specialist (Must Have Trackwise, Complaint Investigations, Trending)

Description

The Specialist, Customer Complaints is responsible for the completion of all tasks associated with complaint management and processing of event reporting, including communication for regulatory compliance with medical device reporting for both domestic and international agency regulations.

• Collaborate with appropriate clinical, technical, and/or regulatory employees to determine product event status and MDR reportability
• Affirms timeliness and compliance with all FDA regulations and standards related to the review of events/complaints for BD products
• Writes and submits eMDR reports to the FDA and Health Canada in strict adherence with regulatory requirements and timelines
• Coincides, researches, and prepares correspondence in response to FDA and global regulatory agencies requests for additional information
• Maintains complaint and MDR file documentation in accordance with regulatory requirements. Completes global complaint handling and adverse event reporting activities related to BD products
• Complies with the site Quality System
• Performs other duties as assigned.

Qualifications

• Education & Experience
• Education: Bachelor’s degree (chemistry, engineering, nursing) strongly preferred
• Experience: 1 to 2 years’ experience in Quality, Regulatory or Complaint management is preferred. May consider equivalent combination of education and experience
• Knowledge, Skills & Abilities
• Knowledge: Working knowledge of QA, Regulatory/Quality Compliance in a medical device industry
• Skills: Attention to detail is essential. Able to utilize computers for development of reports and summary of project experience. Strong proficiency with MS Office tools to include Word, Excel, PowerPoint and Outlook
• TrackWise Complaint Handling System: Prior work experience with TrackWise Complaint Handling System preferred
• eMDR: Prior experience filing eMDRs preferred
• Other Skills: Ability to work on multiple projects with various disciplines are essential. Ability to multitask in an ever-changing environment. Position requires innovative/critical thinking, ability to solve problems and meet deadlines. Strong communication, organization, presentation, and writing skills.