Complaints Handler

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.