Associate MDR/Vigilance Specialist
A global healthcare solutions company is recruiting an Associate MDR/Vigilance Specialist to their Irish office. The organisation focuses on using its medical technology to alleviate pain, restore health, and extend life for people around the world. With over 370 locations across 160 countries, this organisation offers an exciting opportunity to bolster a career in the field of quality assurance.
- Co-ordinating complaint handling activities for a wide range of products including receipt and documenting incoming complaint events.
- Co-ordinating cross-functional activities in the investigation of customer complaints and determining the root cause.
- Supporting the response to any queries received from regulatory agencies in relation to complaint events or post market regulatory reports.
- Supporting complaint trend analysis and issuance of key report to relevant departments.
- Supporting risk management, risk analysis, and health hazard analysis associated with complaint/post-market information.
- Contributing to the continuous improvement activities to support the role out of cell operating systems and principles within the PXM department.
- Monitoring the company's drug or medical devices surveillance program, including the intake, protocol development, evaluation, and processing, and following-up on adverse reports, participating in the resolution of any legal liability, and 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 analysing clinical databases for the extraction of ADE data and integrating 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.
Skills and Requirements:
- Bachelor's degree (Level 8 NFQ) in Engineering/Science or related discipline.
- Candidates with a legal or clinical qualification (e.g. registered nurse or experience in physiological or clinical measurement science) will also be considered.
- Preferably 1-2 years relevant experience in a medical devices or related environment.
- Experience/understanding of complaint handling or CAPA processes are desirable.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact James Wilson at +203 762 2703 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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