Clinician Complaint Handler Consultant

Summary

Join RQM+, a leading MedTech service provider, as a Complaint Handler Consultant. You will support the complaint investigation process for medical devices and combination products, focusing on low-risk complaints and ensuring compliance with regulations. Responsibilities include developing complaint rationales, reviewing reportable decisions, and collaborating with various teams. The role requires a minimum of 5-15 years of experience in complaints and MDR, a Certified RN or PA certification, and excellent communication skills. RQM+ offers a rewarding work environment with an industry-leading compensation package and a focus on work-life balance. The position requires flexibility in scheduling and approximately 25% travel.

Requirements

• Minimum Education: Certified RN or PA
• 5- 15 years of complaints and MDR experience
• Technical Experience: Therapeutic Area/Device Class/Geographies
• Customer focused with excellent communication skills (written and verbal)
• Focused on the direct support of our customers by providing expert technical solutions for device and device constituent related issues using telecommunication, chat or other emerging technologies
• Recognizes the clinical significance of the products and its use
• Displays a sense of urgency to resolve customer issues
• Communicates with empathy and respect to customers, peers and business partners
• Identifies root cause to issues reported by customers and provides appropriate solutions
• Supports Continuous Quality Improvement as well as customer satisfaction goals through modeling of appropriate ethical behavior in the work environment conducive to attaining goals
• Able to clearly explain and present technical information within and outside of the organization (i.e. technical resource to 3rd Party vendors, medical personnel, marketing, service publications, training, R&D, etc.)
• Willingness to work a flexible schedule and travel at least 25% of the time

Responsibilities

• Develop S1 / S2 (low risk) complaint rationale based on reported severity and documented severity in the risk file
• Review any determined S1 / S2 (low risk) severity product quality complaints and S1 / S2 (low risk) adverse events report, evaluate investigation requirements and close with rationale or indicate additional activities
• Required to review any “no” reportable decisions (non-serious complaints) on a weekly basis to ensure appropriate rationale and conclusion
• Reportable and not-reportable decisions to be documented in complaints database
• Supports establishment of complaint handling policies and procedures
• Coordinate activities to generate health hazard assessment in collaboration with medical affairs/safety
• Collaborate with site Quality to ensure issues within scope follow NTM process for proper product containment decisions
• Escalate any new, unknown device risk or hazards, or any event with reported severity greater than the documented severity in the hazard analysis (HA) to Safety for evaluation and assessment
• Coordinate/investigate device complaints in accordance with 21 CFR Part 820.198 and directs events to the appropriate investigating sites (manufacturing site, distribution, design center, safety, and regulatory)
• Determine if an investigation is required and by who for the complaints reviewed
• Review device/combination product complaints investigations
• Review root cause determination of the reported events and assesses any shift in patient risk from reported complaints against the documented risk profile
• Review production, design, use, failure analysis for reported events and related investigations
• Review and evaluate complaints for MDR decisions in accordance with 21 CFR Part 803
• Review users/patients and clinical/safety information for MDR determination
• Coordinate with complaint investigation team to determine if the reported complaint was associated with a malfunction, serious injury or death and whether the complaint documentation is complete and accurate
• Document final reportability of complaints per MDR regulations in accordance with 21 CFR Part 803 and other applicable global regulatory agency requirements
• Ensure submission of complaints requiring an MDR to the FDA and other applicable global regulatory agency requirements and ensure supplemental MDR submitted of the new or added information
• Ensure complete and accurate reporting of complaints as required by applicable regulatory agencies, standards and guidelines
• Ensure high level of quality and consistency in event decision evaluation and reportability of complaints

Benefits

• Industry leading compensation package
• Focus on work life balance