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December 10 2018

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Job Offer: Senior MDR/Vigilance Specialist:Medtronic

Job description:

Senior MDR/Vigilance Specialist


   » Galway
   » Not disclosed
   » Permanent full-time
   » Updated 07/11/2018 this job is expired SaveSave Apply Now

Job detail

MEDTRONIC At Medtronic, we value what makes you unique. Be part of a company that thinks differently to deal with problems, make progress and deliver significant innovations OUR PURPOSE At our Product ...
At Medtronic, we value what makes you unique. Be part of a company that thinks differently to deal with problems, make progress and deliver significant innovations
At our Product practice 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 variety of Medtronic products. Senior MDR/Vigilance Specialist will be part of a high performing Complaint Handling and Medical Device Regulatory reporting department, which provides value all over the Product Life cycle through world class execution in Medical Device Reporting (MDR) and Vigilance compliance.
Come for a job, stay for a career!
Responsibilities may include the following and other tasks may be assigned.
• Oversight of complaint handling activities for a wide variety of Medtronic products. You will be responsible for the secondary approval of regulatory reporting decisions in a designate function. You will also be responsible for the timely submission of US Medical Device Report (MDR) and EU Vigilance Reports to external 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.
• Provide oversight of clinical trial activity with respect to complaint handling and provide appropriate support to the clinical teams as required, including interaction with clinical safety teams.
• Support complaint trend analysis and annual post market surveillance reports for various products.
• Support complaint handling harmonization initiatives with other Medtronic sites globally.
• Support risk management, risk analysis and health hazard analysis connected with complaint/post-market information.
• Support both internal and external audit activities and will interface directly with auditors/inspectors.
• Support any CAPA activities as required.
• Directly manage people and be responsible for communication and coordination of talent management initiatives with reports.
• Contribute to continuous improvement activities to support the function out of cell operating systems and principles within the PXM department and lead problem solving initiatives within the department and coach or mentor other team members.
• Monitor 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 licapability and in complying with government regulations.
• Ensure complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug practice (ADE) data or adverse reaction data as required by regulatory agencies.
• Review and analyze 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.
• Act as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.KEY expertise & practice
• We are seeking for a qualified person to Bachelor's degree (Level 8 NFQ) in Engineering/Science or related discipline and preferably with 5-8 years significant practice in a medical devices or related environment. Candidates with a legal or clinical qualification (e.g. registered nurse or practice in physiological or clinical measurement science) will also be considered.
• We are seeking for a dynamic team player who can work effectively and proactively on cross-functional teams.
• practice/knowledge 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 accountcapability and model ethical behavior.
• Candidates must be a good communicator and are fluent in English, both in writing and speaking.
Ref: 18000H9N
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30 reviews


   » Parkmore Business Park West, Galway
   » +353 91 708000


Job Category: Customer Service [ View All Customer Service Jobs ]
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Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Galway
Company Type Employer
Post Date: 11/07/2018 / Viewed 69 times
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Company: Medtronic
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