MDR/Vigilance Specialist - GALWAY
Cpl Healthcare in partnership with our client is looking to recruit experienced Healthcare Professionals to join their Product Experience Management (PXM) group which is part of the Galway PXM Complaint Handling and Regulatory Reporting Department. Our client is one of the largest global medical device companies with offices in more than 140 countries.
The main focus is on complaint handling and post market regulatory reporting activities for a wide range of the organisations products. The successful candidates 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 and Vigilance compliance.
The ideal candidate must have
- Recognised Healthcare qualification in the area of Nursing, Cardiac/ Respiratory/ ECG Technician.
- Track record working with cross functional teams (MDT’s).
- Good decision making skills, can think critically.
- Focused on patient safety and customer service, set high standards, instils operational excellence, drive accountability and model ethical behaviour.
- Excellent communication and organisational skills essential.
The successful candidates will:
- Co-ordinate complaint handling activities for a wide range of products
- Receive and document incoming complaint events
- Responsible for review of all experiences that our patients or customers (usually health care professionals/doctors) have.
- Be responsible for co-ordination of cross-functional activities in the investigation of customer complaints and determination of root cause
- Support Vigilance and Medical Device Report (MDR) programs including adverse event reporting, preparing documentation on adverse events and ensuring timely submission with relevant regulatory agencies
- Support the response to any queries received from regulatory agencies in relation to complaint events or post market regulatory reports
- Support complaint trend analysis and issuance of key report to relevant departments
- Support risk management, risk analysis and health hazard analysis associated with complaint/post-market information
- Contribute to continuous improvement activities to support the role out of cell operating systems and principles within the PXM department.
- Preferably the ideal candidate will have or had exposure Medronic products or the disease states that they treat. Specifically, the Cardiac Rhythm space (Bradyarrhythmia Management, Tachyarrhythmia Management, Cardiac Mapping etc.) or the Cardiovascular space (Aortic disease, Heart Valve Repair/Replacement, Perfusion, Surgical Revascularization).
We are looking for candidates for the following roles:
- Associate MDR/Vigilance Specialist (1-2 years exp.)
Salary of €35-€40000 Plus benefits
- MDR/Vigilance Specialist (2-3 years exp.)
Salary of €43-€48000 Plus benefit
- Senior /Vigilance Specialist (5-8 years exp.)
Salary of €55-€65,000 Plus benefit
(5% - 10% of yearly salary depending on level)
-Medical and Wellness
Medtronic’s my Health benefit is a flexible healthcare offering whereby employees can use their health allowance to purchase health related benefits to meet their personal needs and the needs of their family. The following health related benefit options will be available for you to choose from:
- 4 Health Insurance Plans
- 1 Dental Insurance Plan
- 6 Gyms in the Galway area
Other elements of Medtronic Total Rewards package include but are not limited to:
- Life Insurance
- Service Days
- Certified Leave
- Bereavement Leave
- Employee Assistance Program (EAP)
- Service Anniversary Awards
- Flexible working time
- Christmas Gift
- Onsite Parking
- Onsite Canteen
For further information on this position please contact Keelin on 086-7826427 or email an up to date CV to email@example.com Apply for job