Sr. Mgr Med Device Prod Complain

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, EU MDR etc. S/he 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 Service groups to process all customer service issues and to identify customer complaints, as required by FDA, Canadian, European and International regulations related to medical device manufacturers and will maintain all complaint and complaint investigation files according to Terumo quality system requirements. This person will work with stakeholder departments such as Engineering, Operations, Clinical, Medical Affairs and Regulatory Affairs on Post Market Surveillance strategy and execution. 

Job Details/Responsibilities

1.    Serve as a member of the TMC Quality Management Leadership Team.  
2.    Oversee medical device complaint processing in compliance with applicable regulations and standards such as FDA Quality System Regulation, 21 CFR Part 820, ISO 13485:2016, EU Medical Device Regulation, etc. 
3.    Drive engagement to ensure personnel have clear expectations, appropriate tools and information, an opportunity to share, grow and develop and are recognized for their contributions.
4.    Serve as a subject matter expert for complex regulatory and compliance issues, including regulatory and procedural interpretations, processes such as risk assessment, investigation, medical device reporting and tracking/trending analysis during audits, inspections and assessments by regulatory agencies and corporate bodies. 
5.    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 and Vigilance Reportings.  If required, ensure reporting takes place in a timely manner. 6.  Identify process improvement opportunities to enhance surveillance and increase efficiency.   
6.    Work closely with manufacturing sites and engineering to ensure thorough and accurate investigations and drive the initiation of product complaint related CAPAs when appropriate
 

Job Responsibilities (continued)

7.    Work closely with new product introduction teams to prepare tools, processes, resources and personnel for complaint management on new product launches.
8.    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.
9.    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.
10.    Manage preparation and reporting of quality data for purposes of Post Market Surveillance and as the primary input into the Management Review process.12. 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.
11.    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.
12.    Coordinate, execute and manage the mobilization of the execution team for global medical device recalls managed by Terumo Medical Corporation..
13.    Keep abreast of industry and regulatory trends and changes.
14.    Performs other job-related duties as assigned.
 

Knowledge, Skills and Abilities (KSA)

• Thorough knowledge of standards and regulations for medical devices complaints and global adverse event reporting.
• Strong analytical skills including trend and statistical analysis, interpersonal, and management skills.
• Demonstrated ability to manage/supervise a team of technical and clinical employees.
• Excellent communication skills and executive presence.
• Strong leadership capabilities – able to manage a team handling high volumes of complaints, able to effectively manage cross-functional relationships and establish clear roles and responsibilities.

• Strong drive to achieve results and meet commitments.
• Demonstrated success at consistently achieving business and quality objectives.

Qualifications/ Background Experiences

• Bachelors degree in science, math or related technical field preferred.
• Minimum 10 years of experience in medical devices or similar regulated industry, at least 5 years in a supervisory role.
• Must be proficient in Microsoft Excel, Word, PowerPoint, and Outlook