Complaint Reporting MDR/Vigilance Specialist 2

Teleflex•Durham, NC

5d•Remote

About The Position

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.

Requirements

B.S. Degree in Nursing, Biomedical Engineering, or related science discipline with a 2-5 years medical device experience, healthcare, quality, accreditation, or regulatory experience.
Demonstrated knowledge of Medical Device Quality Systems regulations including FDA’s 21 CFR 820, 21 CFR 803, ISO 13485:2016, MDD, EU MDR, MDSAP.
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.
Strong organizational, time management, and influence skills with cultural awareness and sensitivity
Excellent verbal and written communication skills with ability to lead meetings.

Nice To Haves

Experience in Post-Market Surveillance, Complaint Handling, Vigilance Reporting, Quality, Risk Management, Clinical Practice, or healthcare accreditation activities (e.g., Joint Commission) preferred.
Experience with risk management - preferred.
Experience with high volume complaints environment - preferred.

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.