Job Summary:
The Senior Manager, Medical Device Product Complaints is responsible for managing medical device complaints in accordance with applicable global regulations (21 CFR Part 820, ISO 13485:2016, MDSAP, EU MDR, etc.) They will be responsible for directing personnel and maintaining all activities associated with customer complaints. S/he will work closely with the Customer Service and Field Clinical groups to process all customer service issues and to identify customer complaints, as required by International regulations related to medical device manufacturers and will maintain all complaint files according to Terumo quality system requirements. This person will work with stakeholder departments such as Quality, Engineering, Operations, Clinical, Medical Affairs and Regulatory Affairs on Post Market Surveillance strategy and execution.
Job Details:
- Customer Complaint Management and Adverse Event Reporting:Oversee medical device complaint processing in compliance with applicable regulations and standards such as FDA Quality System Regulation, 21 CFR Part 803, 21 CFR 820, ISO 13485:2016, EU Medical Device Regulation, MDSAP, etc.
- Manage the timely in-flow of customer complaints, the assignment of investigation responsibilities and expedient processing and closure of complaints to meet corporate QPI metrics.Ensure complaints are properly evaluated for MDR, Adverse Event, Incident and Vigilance Reporting. If required, ensure reporting takes place in a timely manner.
- Identify and implement process improvement opportunities to enhance surveillance and increase efficiency.
- Work closely with manufacturing sites and engineering to ensure thorough and accurate investigations and drive the initiation of product complaint related CAPAs when appropriate.
- Work closely with new product introduction teams to prepare tools, processes, resources and personnel for complaint management on new product launches.
- Assisting RA/QA management and engineering personnel with the identification of quality, reliability and compliance issues from the review and analysis of customer complaint information and trending data and ensuring that all Corrective & Preventive Actions (CAPA) have been identified and assigned according to documented compliance systems.
- Develop and maintain data mining tools to monitor product complaint trends. Define control and/or action limits to detect emerging field issues. Based on surveillance findings, collaborate with technical groups to identify product improvement opportunities; assist in establishing engineering priorities.
- Manage preparation and reporting of quality data for purposes of Post Market Surveillance and as the primary input into the Management Review process. Direct involvement and interface with internal and external auditors, including FDA and Notified Bodies, relating to all activities, reports and files associated with the complaint / MDR and CAPA system processes.
- Establish and maintain complete MDR / Vigilance files and records for all reportable customer complaints to the applicable regulatory authorities. Act as the primary adverse event designee for Terumo Medical Corporation. Responsible for adverse events reporting for designated Terumo affiliates.
- Act as the primary interface with external regulatory agencies on adverse events and additional information requests. Coordinate with other sites and/or functions to ensure a complete and thorough response to the regulatory agencies in a timely manner.
- Post-Market Summary ReportingEstablish processes for the timely creation of post-market summary reports (PMSP, PMSR, PSUR) per EU MDR 2017/745.
- Ensure deliverables are met and delivered to notified bodies in required timeframes.
- Support the develop of product clinical evaluation reports (CER) by supplying post-market performance and industry adverse event/vigilance reporting trends.
- Provide data analysis for product risk management processes throughout the product lifecycle.
- Field Corrections and Removals (Recall) ManagementOversee Terumo’s recall management process by establishing standard processes associated with global recalls.
- Establish cross functional recall management team to create customer notifications and manage recall tracking. When appropriate, engage third party recall management firms to manage recall notification process. Coordinate with QA/RA teams at Terumo entities outside North America to execute recall in local countries.
- Prepare global regulatory agency recall notifications per applicable regulations (ex: 21 CFR 806, Canadian Medical Device Regulation Sections 63, 64, and 65). Interact with global regulatory agencies on recall documentation and questions.
- Performs other job-related duties as assigned.
Position Requirements:
Knowledge, Skills and Abilities (KSAs)
Quality and business process knowledge:
Extensive experience with FDA, ISO 13485, EU MDR, MDSAP and global post-market requirements for medical devices.
Strong analytical skills including trend and statistical analysis. Ability to develop and maintain spreadsheets, pivot tables, metrics, statistical applications, charts/graphs, and user-friendly reports.
Experience interacting with global regulation agencies is audits, recalls, and post-market information requests.
Proven ability to engage with medical professionals on complex complaints in a professional and knowledgeable manner.
Demonstrated process improvement capabilities to ensure compliant and timely post-market activities.
Leadership skills:
Demonstrated ability to communicate and interact with all levels of the organization including Executive Leadership.
- Strong interpersonal skills to provide coaching, training, and direction
- Demonstrated ability to provide clear direction and mentor personnel.
- Proven experience influencing across the organization to improve product or processes.
- Individual skills required:
Strong proofreading and writing skills, as well as exemplary attention to detail
Demonstrated organizational and prioritization skills
Exceptional decision-making including the ability to rapidly understand complex changes and pace work completion to the needs of the company.
Demonstrated initiative and ability to work independently while handling multiple tasks
Strong computer knowledge (MS Office), technical writing skills and proofreading ability
Demonstrated ability to work effectively with cross- functional teams for problem-solving, product and process improvement is required.
Strong drive to achieve results and meet commitments.
Must be proficient in Microsoft Excel, Word, PowerPoint, and Outlook
Background Experiences
- Bachelor’s degree in science, math, engineering or related technical field
- Minimum 10 years of experience in medical devices or similar regulated industry,
- Minimum 5 years in a supervisory role.
