Complaints Specialist

The role

The Complaint Specialist receives, documents, investigates, and resolves product complaints. This role ensures compliance with regulatory requirements and works cross-functionally to support product improvement.

What you will do

• Ensures the processing of complaints in a timely manner by coordinating and prioritizing complaint investigations.
• Communicates with health care providers, staff, and/or patients to acquire relevant complaint information.
• Receives, reviews, and enters product complaint information into the complaints database.
• Participates in root cause investigations in collaboration with cross-functional teams.
• Coordinates and facilitates meetings to discuss complaints and follows up on action items.
• Contributes to the development and improvement of complaint handling procedures, work instructions, and forms.
• Escalates issues to management and supports CAPA activities when necessary.
• Provides customer communication and follow-up regarding complaint resolution status.
• Evaluates complaint information and determines appropriate regulatory reporting requirements.
• Prepares and submits reports to US FDA and other regulatory agencies.

Required qualifications

• 3 years related work experience as a complaint handler in the medical device industry, performing all duties described above.
• Knowledge of medical terms and Medical Device Reporting regulations.
• Exceptional organizational skills and attention to detail.
• Able to perform job function with minimal supervision and work independently.
• Ability to regularly sit or stand for extended periods of time.

Nice to have

• Bachelor’s degree in technical, scientific, or business-related discipline

About the company

Spectrum Vascular is an innovative medical device company focused on vascular access and medication management. The company was formed through the acquisition of a portfolio of trusted products.