Complaint Reporting MDR/Vigilance Specialist 2

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. Responsible for preparation and timely submissions of MDR/Vigilance reports to FDA/Competent Authorities and other regulatory agencies. Where necessary, seek and document relevant additional information in line with the complaint intake process. Identify potential issues to continuously improve process.

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Principal Responsibilities

•    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.
•    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 initial reports
•    Support 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 a 1-3 years medical device experience.
•    Experience in Post-Market Surveillance with preference for experience in Complaint Handling/Vigilance Reporting.
•    Demonstrated knowledge of Medical Device Quality Systems regulations including FDA’s 21 CFR 820, 21 CFR 803, ISO 13485:2016,   MDD, EU MDR, MDSAP.

Specialized Skills / Other Requirements

•    Ability to critically review information and seek clarification.
•    Ability to work well under deadlines and pressure in a changing environment.
•    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.

•    Self-driven and ability to work independently and/or as a team player.
•    Approachable and enthusiastic. Flexible and adaptable.
•    Good judgment and problem-solving ability & is capable of understanding the impact of decision making on both Teleflex Medical and         their customers.
•    Experience with risk management - preferred.
•    Experience with high volume complaints environment - preferred.
•    Strong organizational, time management, and influence skills with cultural awareness and sensitivity
•    Excellent verbal and written communication skills with ability to lead meetings.