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Medtronic

Assoc MDR/Vigilance Spec

Medtronic

  • Galway
  • Not disclosed
  • Permanent full-time
  • Updated 03/01/2018
this job is expired
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Description

FURTHER, TOGETHER Together, we will change healthcare worldwide. Join us in our Mission to alleviate pain, restore health and extend life worldwide. Let’s work together to address the universal he...

 

FURTHER, TOGETHER
Together, we will change healthcare worldwide. Join us in our Mission to alleviate pain, restore health and extend life worldwide. Let’s work together to address the universal healthcare needs and improve patients’ lives, optimize costs and efficiencies, and expand global access. Together, we can make a real difference in the global disparity in care. By providing quality care at the lowest possible cost, we will succeed as a company, and take the future of healthcare Further, Together.

OUR PURPOSE
At our Product Experience Management (PXM) group, which is part of the Galway PXM 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. You 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.

OUR OFFER
You will be responsible for the co-ordination of complaint handling activities for a wide range of Medtronic products. You will be responsible for the receipt and documenting of incoming complaint events. You will also be responsible for co-ordination of cross-functional activities in the investigation of customer complaints and determination of root cause. You will also 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. You will also support the response to any queries received from regulatory agencies in relation to complaint events or post market regulatory reports. You will also support complaint trend analysis and issuance of key report to relevant departments. You will support risk management, risk analysis and health hazard analysis associated with complaint/post-market information. You will contribute to continuous improvement activities to support the role out of cell operating systems and principles within the PXM department. YOUR PROFILE
We are looking for a qualified person to Bachelor’s degree (Level 8 NFQ) in Engineering/Science or related discipline and preferably with 1-2 years relevant experience in a medical devices or related environment. Candidates with a legal or clinical qualification (e.g. registered nurse or experience in physiological or clinical measurement science) will also be considered. We are looking for a dynamic team player who can work effectively and proactively on cross-functional teams. Experience/understanding of complaint handling or CAPA processes are desirable. Candidates must be able to think critically and make sound decisions. Candidates must be focused on patient safety and customer service, set high standards, instils operational excellence, drive accountability and model ethical behavior. Candidates must be a good communicator and are fluent in English, both in writing and speaking.

Leadership Expectations provide the framework for what we expect from all employees at Medtronic – outlining the actions and behaviors we must develop and demonstrate in pursuit of our Mission and global growth goals.

SHAPE
We are committed to being experts in what we do, with a clear vision of where we are going and the plan to get there.
■ Demonstrates Global Business Acumen
■ Thinks Critically and Makes Sound Decisions
■ Sets Strategic Direction

ENGAGE
We partner with and involve others, knowing that diverse talent, skills, and perspectives lead to better outcomes.
■ Collaborates and Creates Alignment
■ Attracts, Deploys, and Develops Talent
■ Fosters Diversity and Inclusion

INNOVATE
We are bold thinkers who create new ideas and bring our best solutions forward to benefit our patients, partners, and customers.
■ Focuses on Patient and Customer
■ Generates Breakthrough Ideas
■ Initiates and Leads Change

ACHIEVE
We do what we say we are going to do, delivering results with the highest standards.
■ Sets High Standards
■ Instils Operational Excellence
■ Drives Accountability
■ Models Ethical Behavior

Ref: 17000L0W
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