Team Lead Complaint Reporting MDR/Vigilance

About Teleflex Incorporated 

Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com. 

Position Summary

Work within Complaint Intake & Reporting team to critically review complaints to determine reportability based on the regulatory requirements, risk documentation and clinical experience. Additionally, ensures timely closures and interfacing with suppliers for investigations. Coordinates distribution of work lists and adjusts operations accordingly. Prepare and submit MDR/Vigilance reports to FDA/Competent Authorities and other regulatory agencies. Manages the Complaint Reporting MDR/Vigilance Specialists who are responsible for preparing, submitting, and closing the complaint files. Ensures all Medical Device Reports to the FDA, the EU, and other regulatory agencies worldwide are in conformance with applicable local, regional, and international regulations.

Principal Responsibilities

Key responsibilities will include (but are not limited to) the following:
•    Manages the Complaint Reporting MDR/Vigilance Specialists who are responsible for preparing and submitting Medical Device Reports to the FDA/Competent Authorities and other regulatory agencies and assisting with submissions to other regulatory agencies worldwide in conformance with applicable local, regional, and international regulations.
•    Utilizes clinical experience in conjunction with risk management documentation to review complaints for adverse event reportability in accordance with US Canadian & European regulations within required time frames.
•    Follows up with health care providers and customers to provide clarification for complaint files and document correspondence to complaint files as required.
•    Follows up with suppliers to ensure timely receipt of investigations and documents correspondence to complaint files as required.
•    Prepare and submit regulatory reporting documentation such as MedWatch forms with FDA and Vigilance Reports with Canadian and European regulatory authorities.
•    Assist as clinical liaison for the complaint management department to facilitate understanding of clinical application for product complaint devices and provide training to other team members as required.
•    Utilize complaint management system to accurately document complaint information.
•    Final Reviewer/Approval of reporting decisions and follow-up/final reports
•    Lead in the review and evaluation of escalated incident reports.
•    Leads training and qualification of new staff.
•    Leads audit activities are required. Assists with responses to FDA and Competent Authority for additional information queries.
•    Work to meet team KPI’s Department Metrics and over QA/RA goals and objectives.
•    Support improvement projects in the complaint intake and reporting function
•    Support wider QMS and risk management activity as required

Education / Experience Requirements

•    B.S. Degree in Nursing, Biomedical Engineering, or related science discipline with   demonstrated experience in medical procedures - Essential
•    A minimum of 5 years of experience in Post-Market Surveillance, including proficiency in Complaint Handling and Vigilance Reporting. Alternatively, a minimum of 5 years of experience leading risk mitigation activities within a clinical setting can be considered in lieu of specific experience in complaint handling and vigilance reporting. 
•    Ability to critically review information and seek clarification
•    Ability to work well under deadlines and pressure in a changing environment.
•    Advanced computer skills, including statistical/data analysis and report writing skills.
•    Skilled in use of Microsoft suite of applications i.e., Excel, Outlook, and Word.
•    The ability to prioritize tasks and be able to manage several tasks simultaneously.
•    Ability to read understand and self-educate on emerging regulatory requirements.
•    Good working knowledge of QMS (Quality Management System) and or RMS (Risk Management System)
 

Specialized Skills / Other Requirements

KEY RELATIONSHIPS / INTERFACES
•    Manager, Complaint Reporting MDR/Vigilance
•    Global Manager, Complaint Intake
•    QARA Snr Manager