Complaint Reporting MDR/Vigilance Specialist 2
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.
Responsibilities
Utilize 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.
Follow 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 of 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 as required and assist 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 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.
Ability to prioritize tasks and manage several tasks simultaneously.
Ability to read, understand and self-educate on emerging regulatory requirements.
Self‑driven and able to work independently and/or as a team player.
Approachable, enthusiastic, flexible, and adaptable.
Good judgment and problem‑solving ability, capable of understanding the impact of decision making on both Teleflex Medical and its 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.
Teleflex is an equal opportunity employer. Applicants will be considered without regard to age, gender, race, nationality, ethnicity, civil status, family status, sexual orientation, disability, religion and/or membership of the traveller community. If you require accommodation and support to apply for a position, please contact us at talent.emea@teleflex.com.
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