Date: Mar 3, 2025
Location: Athlone, L, IE
Company: Teleflex
Expected Travel: Up to 10%
Requisition ID: 11894

POSITION SUMMARY

Work within Complaint Intake & Reporting team to accurately document customer reported product complaints. Review complaint details to ensure all relevant information has been received to determine reportability based on the regulatory requirements. Complete initial reporting decisions based on regulatory requirements, risk documentation and supporting procedures. Where necessary seek and document relevant additional information and facilitate sample return in line with the complaint intake process.

EDUCATION / EXPERIENCE REQUIREMENTS

• A relevant Degree in a related field/ experience of working within in a medical device environment preferable
• One – two years experience in the specified area of responsibility.
• Good PC skills: Excel, PowerPoint, Word, Outlook and SAP
• Must be fluent in English both spoken and written
• Working knowledge of EU MDR regulatory requirements.
• Strong ability to understand interaction with people and dynamics
• Critical thinking and awareness to escalate to the appropriate function for appropriate action essential
• Flexible, motivated, self-starter capable of working from their own initiative and or part of a team
• Effective administration, organizational and prioritization skills
• Strong attention to detail Ability to analyse information, and solve problems
• The ability to work effectively to strict deadlines
• The ability to interface with all levels of management in a competent manner

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.
• Uses excellent communication skills when contacting the customer to follow up on a complaint in order to gather additional information and obtain device returns.
• Support the sales and investigation teams with complaint related customer communications.
• Document all relevant information in the complaint management system to ensure internal and external regulatory requirements are fulfilled.
• Support Adverse Event Reporting Regulatory Requirements.
• Draft customer letters as required.
• Monitor/triage customer complaints and provide immediate escalation as required.
• Support other activities in the post-market surveillance system as it develops including audits.
• Work to meet team KPI’s Department Metrics and other QA/RA goals and objectives.
• Support process improvement projects in the complaint intake and reporting function.
• Other duties as assigned.