Pms Analyst - County Offaly

ICDS Recruitment

Waterford

PMS Analyst - County Offaly. This is being offered as an initial 6 month' contract. The PMS Analyst is responsible for ensuring that the company meets its statutory regulatory obligations under the Medical Device Vigilance requirements of the Medical Device Directive (MDD) within the EEA, and comparable reporting responsibilities in other countries in EMEA. JOB FUNCTIONS. The PMS Analyst will carry out the following duties: Complete and file Initial and Final Device Vigilance Reports, for all Incidents deemed reportable by designated personnel at the Global Business Units (GBUs), in accordance with reporting timeframes. Liaise with GBUs and in-country RA personnel, where the relevant Competent Authority (CA) requires additional information and/or clarifications. Provide supplementary information to the Competent Authorities, and follow-up with GBUs in a timely manner, in order to ensure that CAs’ timelines are met, wherever possible. Maintain familiarity with MDD and any associated Directives, MEDDEVs, and national legislation, ensuring compliance with updated regulations, wherever applicable, in accordance with regional and corporate procedures. Review decision-trees and other supporting information in the Complaint Tracking System, in order to understand rationale /decision on whether incidents are reportable. Query rationale where necessary and advise RA Manager EMEA wherever the analyst believes that the rationale for the decision may not be discernible to the CA without further enquiry. Assist with communication with Competent Authority, and work with in-country RA personnel, where directed by RA Manager EMEA, in coordinating follow-up meetings or contact with the CA, per a clearly defined agenda. EXPERIENCE REQUIRED: • Applicants should ideally have 2/3 years' experience of working within a highly regulated environment (preferably healthcare), and have experience in communicating with government or statutory authorities. • Applicants should have the ability to generate and review reports on regulatory matters in a timely manner, and be accountable for the accuracy and integrity of information provided as input for decision-making. • Applicants should ideally have a working knowledge of fundamental healthcare-related processes, and be able to review detailed responses to Competent Authorities – including Instructions for use (IFUs), dimensional analyses, reports, complaint-data etc. – for completeness, relevance and accuracy. This job originally appeared on RecruitIreland.com.

2794 days ago