Medical Device Complaints Specialist

About the Role The role provides effective technical support to the complaint handling process, resolves client issues, and escalates to meet process SLAs. It involves managing complaints from intake to closure, coordinating with SMEs, QAs, and Team Leads, and ensuring readiness for MDR reporting when applicable. What You'll Do

• Receives customer complaints through calls, emails, and faxes.
• Ensures accurate capture and entry of complaint information and owns the complaint handling process.
• Assesses complaints (events) for proposed MDR reportability and submits assessment to the client.
• Follows up for additional information and product returns.
• Acts as the primary, single-source customer contact.
• Gathers event registration information (as defined by SOPs) from customers and manages the event through registration, potential regulatory reporting, sample retrieval, investigation, and customer response to closure/reopening as needed.
• Contacts subject matter experts (SMEs), QA, and Team Lead as needed to obtain complaint closure.
• Escalates significant events to the Team Lead in a timely manner.
• Adheres to all company policies and procedures including Information Security Management Systems and maintains confidentiality of customer information.
• Performs reviews and assessments of complaints processed by peers as part of cross-utilization. What We're Looking For
• Qualifications: Bachelors of Science in Nursing or Pharmacy Allied Medical Graduate; preferably with clinical experience and/or RN/Pharmacist.
• Additional Skills: Medical/Technical narrative writing, creating customer letters, strong computer/keyboard skills, excellent telephonic and listening skills, critical thinking for information gathering, problem solving and analytical skills, excellent customer service. Nice to Have
• Clinical experience or regulatory/compliance exposure; familiarity with MDR reporting is a plus. Compensation & Benefits
• Performance metrics include: number of cases resolved per day, compliance to process and quality standards, meeting process-level SLAs, Pulse score, and customer feedback.
• Self-management metrics include: productivity, efficiency, absenteeism, training hours, and number of technical trainings completed.