Sr Manager, Global Complaint Intake & Reporting

Position Summary

This position is responsible for managing a team responsible for receiving, processing, monitoring, and reporting the product quality customer complaints received by Teleflex. The scope of this role includes responsibility for intake of complaints, Adverse Event Reporting, and regulatory follow up. The Sr. Manager will work closely with the rest of Product Quality Assurance to address post market data and inform senior management as required on relevant issues.  The successful candidate will also be responsible for maximizing team performance, setting team KPIs and meeting department metrics.

Principal Responsibilities

•    Responsible for the Teleflex Complaint Handling and Reporting processes and procedures, including but not limited to

o    Establish compliant and efficient complaint handling & adverse event reporting process across the company 

o    Adapt and revise processes as needed to ensure ongoing compliance with newly released standards and guidances 

o    Work with global counterparts, especially Teleflex regional regulatory partners, to enact compliant and effective processes that ensure timely processing & submission of complaints in each region

o    Implement practices for complaint queries (addition information requests), follow-up and completion of appropriate responses and tracking 

o    Work with QARA Management from throughout Teleflex to improve and streamline processes and systems needed to support both local and global targets and objectives.

•    Ensure systems/databases (e.g. SAP, Veeva Vault, Pilgrim, Agile, etc.) are developed and maintained for centralized complaint administration, trending, and reporting. Support implementation of an integrated complaint management IT system across the enterprise.

•    Collect, summarize, and evaluate data for reporting to Sr. Management, including via management review meetings. Utilize data and performance to identify program weaknesses and make continuous improvements in procedures, staffing, or oversight of the function.

•    Serve as the complaint handling subject matter expert for audits, management reviews, and electronic QMS implementation. 

o    Serve as PRRC for the reporting obligations referred to EU MDR Articles 87 to 91 

o    Support enterprise-wide audits, both directly (i.e. front room) and indirectly 

o    Communicate with FDA, competent authorites (e.g. HPRA) or other interested internal and external parties as needed

•    Develop and monitor business practices and personnel requirements for Complaint Intake & Reporting department, including managing personnel, monitoring budget, contracting services and developing relationship with key business partners

o    Hire, train, coach and mentor personnel to develop an engaged and effective team

o    Develop goals, objectives and KPIs and conduct regular reviews for continuous improvement

•    Maintain close working relationships with Product Quality Assurance, Regional RA, Clinical Medical Affairs, Legal Counsel, and Field Corrective Action groups in US and EMEA.

•    Perform other duties as required.

Education / Experience Requirements

•   Bachelor’s degree or equivalent with 10 years combined experience in medical device complaint handling, medical device adverse event reporting and/or clinical experience.

•    Minimum 5 years experience in managing teams, specifically Post Market Surveillance, Complaint Handling, Vigilance Reporting or Regulatory Affairs

•    Extensive knowledge and understanding of Quality and Regulatory requirements and regulations, including but not limited to FDA's 21 CFR Part 820 & 803 (Quality System Regulation), ISO 13485 Quality System requirements, Council Directive 93/42/EEC (Medical Device Directive), MEDDEV, Canadian Medical Device Regulations, Japanese JPAL requirements.

Specialized Skills / Other Requirements

•    Experience performing internal and external audits

•    Excellent attention to detail and the ability to communicate clearly and accurately, verbally and in writing.

•    Knowledge and experience with corrective and preventive actions systems.

•    Knowledge and experience in process monitoring methods and techniques.

•    Experience with QMS Applications, specifically Agile, SAP, or Veeva Vault preferred. 

•    Additional language skills is beneficial