仕事内容

Role Overview

We are looking for a Complaint Handling Specialist to support post-market quality work, complaint investigations, and evaluations tied to regulatory reporting. This role is suited to someone who has handled product complaints in a regulated setting and can maintain accurate, compliant records in line with internal procedures.

Key Responsibilities

Receive, record, and manage product complaint cases according to company procedures and regulatory expectations.
Carry out first-pass complaint reviews and work with cross-functional partners to drive investigations.
Assess whether complaints need escalation or formal reporting.
Keep complaint documentation complete, precise, and ready for audit review.
Monitor complaint patterns and contribute to related metrics and reporting.
Work closely with quality, regulatory, manufacturing, and engineering teams on root-cause analysis and corrective actions.

Qualifications

A bachelor’s degree in Life Sciences, Engineering, or a similar field is preferred, though equivalent experience may be considered.
At least 2 years of experience in complaint handling, quality systems, or post-market surveillance.
Working knowledge of FDA and/or ISO quality system requirements.
Strong ability to document findings clearly and investigate issues thoroughly.
Comfort managing a large volume of cases while maintaining strong attention to detail.

Preferred Experience

Background in the medical device or pharmaceutical industry.
Exposure to MDR, vigilance, or other post-market reporting obligations.
Experience with complaint management tools or electronic quality systems.

Additional Information

This is a remote contract role with an expected length of 18+ months.

Complaints Handler