Senior Medical Device Complaints Manager

3 days ago

Elkton, Maryland, United States Terumo Medical Corporation Full time
Job Summary

The Senior Manager, Medical Device Product Complaints is responsible for overseeing medical device complaints in accordance with applicable global regulations. This includes directing personnel and maintaining all activities associated with customer complaints, working closely with the Customer Service and Field Clinical groups to process all customer service issues, and identifying customer complaints as required by International regulations related to medical device manufacturers.

Key Responsibilities
  • Manage 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.
  • Oversee the timely in-flow of customer complaints, the assignment of investigation responsibilities, and the expedient processing and closure of complaints to meet corporate QPI metrics.
  • Ensure complaints are properly evaluated for MDR, Adverse Event, Incident, and Vigilance Reporting, and 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.
  • Assist 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 ensure that all Corrective and 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, and collaborate with technical groups to identify product improvement opportunities.
  • Manage the 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 and 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, and coordinate with other sites and/or functions to ensure a complete and thorough response to the regulatory agencies in a timely manner.
  • Establish 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, and support the development 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.
  • Oversee Terumo's recall management process by establishing standard processes associated with global recalls, establish cross-functional recall management teams to create customer notifications and manage recall tracking, and engage third-party recall management firms to manage recall notification processes when appropriate.
  • Prepare global regulatory agency recall notifications per applicable regulations and interact with global regulatory agencies on recall documentation and questions.
Requirements
  • 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, and the ability to develop and maintain spreadsheets, pivot tables, metrics, statistical applications, charts/graphs, and user-friendly reports.
  • Experience interacting with global regulatory agencies in 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, including the ability to communicate and interact with all levels of the organization, including Executive Leadership, and provide coaching, training, and direction.
  • Strong interpersonal skills, including the ability to provide clear direction and mentor personnel, and influence across the organization to improve products or processes.
  • Individual skills required, including strong proofreading and writing skills, exemplary attention to detail, demonstrated organizational and prioritization skills, exceptional decision-making, demonstrated initiative and ability to work independently while handling multiple tasks, and strong computer knowledge (MS Office), technical writing skills, and proofreading ability.
  • Background experiences, including a Bachelor's degree in science, math, engineering, or a related technical field, and a minimum of 10 years of experience in medical devices or a similar regulated industry, with a minimum of 5 years in a supervisory role.

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