Specialist I, Complaint Reporting MDR/Vigilance

Position Summary

Junior member of the complaint Intake & Reporting team, responsible for evaluating complaints to determine if they need to be reported to regulatory bodies like the FDA, prepare and submit necessary reports, and gather additional information as required during the complaint process. This role is ideal for someone detail-oriented and passionate about regulatory processes.

Principal Responsibilities

Key responsibilities will include (but are not limited to) the following:
•    Receive, review and accurately document and process product complaints in line with regulatory and internal requirements.
•    Use excellent communication skills when contacting the customer to follow up on a complaint to gather additional information regarding the complaint file. This also includes drafting responses to customers as needed.
•    Under limited supervision, prepare and submit regulatory reporting documentation such as MedWatch forms with FDA and Vigilance Reports with Canadian and European regulatory authorities.
•    Support other activities in the post-market surveillance system as it develops including audits.
•    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.
•    At least 1 year experience in the medical device industry or clinical trials sector preferable. 
•    Skilled in use of Microsoft suite of applications i.e., Excel, Outlook, and Word to perform diverse clerical functions within a professional work environment

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Specialized Skills / Other Requirements

•    Self-driven Self-confident to prioritise tasks, and influence skills with cultural awareness and sensitivity.
•    Critical thinking and awareness to escalate to the appropriate function for appropriate action.
•    A flexible, motivated, self-starter capable of working from their own initiative. 
•    Advanced knowledge of Word, Excel, PowerPoint, Outlook. 
•    Effective administration, organizational and prioritization skills. 
•    Strong attention to detail. 
•    The ability to work effectively to strict deadlines.
•    Strong report writing & communication skills. 
•    The ability to interface with all levels of management in a competent manner.
Note:  As with all positions, due to the dynamic nature of Teleflex Medical business, key responsibilities will evolve and change over time.