Customer Complaints Specialist (Must Trackwise, Complaints Investigations & Trending)

Position : Customer Complaints Specialist (Must Trackwise, Complaints Investigations & Trending)

Location : San Diego, CA

Duration : 12 Months contract

Total Hours/week : 40.00

Client: Medical Device Company

Level Of Experience: Mid-Level

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Or OPT EAD Or CPT)

3 Must haves on the resume:

• Experience with Trackwise
• Experience with Complaint Investigations
• Experience with Complaint Trending

Job 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.

Job responsibilities, not limited to:

• Collaborate with appropriate clinical, technical, and/or regulatory employees to determine product event status and MDR reportability
• Assures timeliness and compliance with all FDA regulations and standards related to the review of events/complaints for client products
• Write and submit eMDR reports to the FDA and Health Canada in strict adherence with regulatory requirements and timelines.
• Coordinate, research, and prepare correspondence in response to FDA and global regulatory agencies requests for additional information
• Maintain complaint and MDR file documentation in accordance with regulatory requirements.
• Completes global complaint handling and adverse event reporting activities related to client products
• Comply with the site Quality System.
• Performs other duties as assigned.

Qualifications:

Education & Experience

• Bachelor’s degree (chemistry, engineering, nursing) strongly preferred.
• 1 to 2 years’ experience in Quality, Regulatory or Complaint management is preferred.
• May consider equivalent combination of education and experience.

Knowledge, Skills & Abilities

• Working knowledge of QA, Regulatory/Quality Compliance in a medical device industry.
• 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.
• Prior work experience with TrackWise Complaint Handling System preferred.
• Prior experience filing eMDRs preferred.
• 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.