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Contact Info
Jack Caffrey
Life Science

01 507 9279
[email protected]
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Details

Assoc MDR/Vigilance Specialist


Reference:JSC45161 Location: Galway
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: EHS Specialist, Validation Scientist

We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Galway. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

At our Customer Quality Experience Management (CQXM) group, which is part of the Galway Complaint Handling and Regulatory Reporting Department in Medtronic, plc, we focus on complaint handling and post market regulatory reporting activities for a wide range of Medtronic products. Successful candidate will be part of a high performing Complaint Handling and Medical Device Regulatory reporting department, which provides value throughout the Product Life cycle through world class execution in Medical Device Reporting (MDR) and Vigilance compliance.
Part of a team responsible for the management of all incoming product events from a range of sources and geographies.
Responsible for the data entry of field complaints reported for medical devices into complaint database, including documentation review and complaint assessment.
Support Vigilance and Medical Device Report (MDR) regulatory reporting by ensuring timely assessment of incoming complaint events.
Support complaint trend analysis and issuance of key reports to relevant departments.
Contribute to continuous improvement activities to support efficiency and productivity gains opportunities within the PXM department.
Build product knowledge and technical expertise of the product group you support.
Adherence to procedures at all times to ensure compliance.
Ensure highest quality of product event data entry for accuracy of reporting to regulatory agencies.

Education & Experience

Qualified person to Bachelor’s degree (Level 8 NFQ) in Engineering/Science or related discipline.
Dynamic team player, attention to detail, goal-orientated, good communicator and problem solving skill-sets.
Medical device experience desirable
100% desk based
Autonomy: Established and productive individual contributor.
Works independently with general supervision primarily on larger, moderately complex projects / assignments.
Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments.
Contributes to the completion of project milestones .
May have some involvement in cross functional assignments.
Innovation and Complexity: The problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex.
Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
Communication and Influence: Communicates primarily and frequently with internal contacts.
External interactions are less complex or problem solving in nature.
Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making.