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

Location: San Diego, CA | Duration: 12-month contract | Hours: 40/week | Employment Type: W2 contract (US Citizens, GC holders, OPT EAD, or CPT only)

About the Role

The Customer Complaints Specialist is responsible for complaint management, event reporting, and ensuring regulatory compliance with medical device reporting for both domestic and international agencies.

Responsibilities

• Collaborate with clinical, technical, and regulatory teams to determine product event status and MDR reportability.
• Ensure timeliness and compliance with FDA regulations and standards for event/complaint review.
• Write and submit eMDR reports to the FDA and Health Canada in strict adherence to regulatory requirements and timelines.
• Coordinate, research, and prepare responses to FDA and global regulatory agencies' requests for additional information.
• Maintain complaint and MDR file documentation per regulatory requirements.
• Complete global complaint handling and adverse event reporting activities for client products.
• Comply with the site Quality System.
• Perform other duties as assigned.

Requirements

Must-have experience (required on resume):

• Trackwise
• Complaint Investigations
• Complaint Trending

Qualifications

• Bachelor’s degree (chemistry, engineering, nursing) strongly preferred.
• 1–2 years of experience in Quality, Regulatory, or Complaint management preferred (or equivalent combination of education and experience).
• Working knowledge of QA, Regulatory/Quality Compliance in the medical device industry.
• Strong attention to detail.
• Proficiency with MS Office (Word, Excel, PowerPoint, Outlook).
• Prior experience with TrackWise Complaint Handling System preferred.
• Prior experience filing eMDRs preferred.
• Ability to work on multiple projects across various disciplines.
• Strong problem-solving, communication, organization, and writing skills.
• Ability to multitask in a fast-paced, evolving environment and meet deadlines.