A Major Global Medical devices Company in Galway, Ireland is recruit a suitably qualified person for the following post
SENIOR MEDICAL DEVICE REPORTING/VIGILANCE SPECIALIST
At our Product Experience Management (PXM) group, which is part of the Galway PXM Complaint Handling and Regulatory Reporting Department, we focus on complaint handling and post market regulatory reporting activities for a wide range of Company products. Senior MDR/Vigilance Specialist 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.
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.
* Oversight of complaint handling activities for a wide range of Company products. You will be responsible for the secondary approval of regulatory reporting decisions in a designate role. 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 Company sites globally.
* Support risk management, risk analysis and health hazard analysis associated 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 role 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 liability and in complying with government regulations.
* Ensure 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.
* 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 SKILLS & EXPERIENCE
* We are looking for a qualified person to Bachelor's degree (Level 8 NFQ) in Engineering/Science or related discipline and preferably with 5-8 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.
Renumeration: An excellent Salary/Benefits on offer and negotiable
Please forward your CV in word format to:
Informal inquiries to Christy O'Hara on 087-9473404 or 00353 879473404 if outside Ireland