At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Medtronic

At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress and deliver meaningful innovations.

Our Purpose

At our Customer Quality and Experience Management (CQXM) group, which is part of the Galway CQXM 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.

Come for a job, stay for a career!

A Day in The Life Of:

Responsibilities may include the following and other duties may be assigned.

• Supervision of complaint handling activities for a wide range of Medtronic products and managing timely approval of regulatory reporting decisions.
• Timely submission of US Medical Device Report (MDR) and EU Vigilance Reports to external regulatory agencies.
• Supporting the coordination of cross functional responses to any queries received from regulatory agencies in relation to complaint events or post market regulatory reports.
• Ensuring adequate support of complaint trend analysis and annual post market surveillance reports for various products.
• Supporting complaint handling harmonization initiatives with other Medtronic sites globally.
• Supporting risk management, risk analysis and health hazard analysis associated with complaint/post-market information.
• Contributing to continuous improvement activities to support the role out of cell operating systems and principles within the CQXM department. You will also lead critical problem-solving initiatives within the department and coach or mentor other team members.
• Supervising direct reports and managing their performance and supporting them to enable their development within the organization.
• Monitoring the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports, participation in the resolution of any legal liability and in complying with government regulations.
• Ensuring complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.
• Reviewing and analyzing clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database consistent with the aims and purposes of ADE standardization and internalization as well as to ensure the accuracy and quality of safety summaries.
• Acting as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.

Key Skills & Experience

• We are looking for a person qualified to a Level 8 Degree in Science, Engineering or related discipline with a minimum of 3 year’s relevant experience.
• Candidates with a legal or clinical qualification (e.g. registered nurse or experience in physiological or clinical measurement science) will also be considered.
• Candidate must be a dynamic team player and leader and can work effectively and proactively on cross-functional teams.
• Candidate must be able to think critically and make sound decisions and experience in Complaint handling or risk management would also be desirable.
• Candidate must be focused on patient safety and customer service, set high standards, instil operational excellence, drive accountability and model ethical behaviour.
• Candidates must be a good communicator and fluent in English, both in writing and speaking.

Medtronic offer a competitive salary and flexible Benefits Package

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
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