Customer Complaints Management Specialist

Location: San Diego, CA • Duration: 12 months • Schedule: 8:30 AM–5:00 PM, Monday–Friday • Employment Type: W2 contract (US citizens or Green Card holders only)

About the role

The Specialist, Customer Complaints is responsible for 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 agencies.

Responsibilities

• Collaborate with clinical, technical, and/or regulatory employees to determine product-event status and MDR reportability.
• Ensure 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-agency requests for additional information.
• Maintain complaint and MDR file documentation in accordance with regulatory requirements.
• Complete global complaint-handling and adverse-event reporting activities related to client products.
• Comply with the site Quality System.
• Perform other duties as assigned.

Requirements

• Bachelor’s degree (chemistry, engineering, nursing) strongly preferred; equivalent combination of education and experience may be considered.
• 1–2 years’ experience in Quality, Regulatory, or Complaint management is preferred.
• Working knowledge of QA, Regulatory/Quality Compliance in the medical-device industry.
• Attention to detail is essential.
• 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.
• Ability to multitask in an ever-changing environment.
• Innovative/critical thinking, problem-solving, and deadline-meeting skills.
• Strong communication, organization, presentation, and writing skills.

Must-haves on resume: Quality Complaint experience, prior medical-device experience, ISO 13485 / 21 CFR 820 regulation experience.