Snr Regulatory Affairs Communications Sp

ICDS RECRUITMENT

LIMERICK

Senior Regulatory Affairs Communications Specialist – Post Market (Adverse Event Reporting & Field Actions)- Limerick. In this role you will supervise and manage a team of RA specialists with responsibility for the Adverse Event Reporting and Field Action for medical devices. Core Responsibilities: • Responsibility for implementing regulatory requirements for adverse event reporting and field action in accordance with ISO13485, MDD 93/42/EEC, EU MDR 2017/745 and FDA 21CFR Parts 806, 803, 820 and other jurisdictions as required. • Supervise and manage a team of Regulatory Affairs Communications Specialists: managing day-to-day workload and operational issues. Set team objectives and monitor performance. Provide coaching and support and acting as a point of escalation where necessary. • Ensure that complaints are assessed for Regulatory Reporting; this includes Adverse Event Reporting (MDR, Vigilance, etc) and associated correspondence to applicable Regulatory bodies including peer review of same. • Review and approve Adverse Event Reports that are generated by the team prior to submission to relevant Competent Authority / Regulatory Authority. • Ensure all reports are submitted within the required timeframes for adverse event reporting and field actions. • Conduct the AE re-assessment of all complaints when additional information is received. • Conduct regulatory review and assessment of trends and submission of trend reports where relevant. • Conduct the manufacture final review and send files to Customer Relations team for closure. • Co-ordinate the weekly regulatory reporting requirements with the Quality Engineering function. Ensure metrics for this area are monitored and reported to management when necessary. • Conduct Health Risk Assessment (HRA) regulatory reporting assessments as necessary in relation to any potential issues that may lead to a field action. • Draft / review of any Field Safety Notices (FSNs), Field Safety Corrective Actions (FSCAs), Customer Letters, Global Recall Documentation and liaising with local Customer Relations, company affiliates and/or distributors as required. • Recall co-ordination (including Competent Authority responses) – Global and Local as appropriate. • Serve as a liaison on regulatory issues between the company and affiliates and/or distributors. • Participate in internal and external audits as Subject Matter Expert in Adverse Event Reporting and Field Action. • Provide support for Post Market Surveillance, Clinical Evaluation Reports and Regulatory Marketing Authorisation submissions by providing summary adverse event and field action information when required. • Review and approve Post Market Surveillance, Post Market Clinical Follow Up and Clinical Evaluation activities as required. • Report relevant information in Management Review. • Actively pursue ways in which to improve the function of the Regulatory Affairs Department supporting continuous improvement activities. • Act as a designee for the RA Manager and Regulatory Specialists as required. Qualifications / Requirements: • Third level Qualification in Science/Quality preferred. • At least 5 years' experience in a regulated industry in a similar role. • Ideally have knowledge of requirements in MDSAP countries including regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU MDR 2017/745 and FDA QSP 21CFR Part 820 as required. • Knowledge of requirements in other jurisdictions where required. • Knowledge of medical device quality standards/practises or similar regulated industry. • Previous experience in using Trackwise or equivalent complaints handling system. • Proven decision-making capabilities & problem-solving skills. • Good communication and inter-personal skills. • Good computer skills including knowledge of Microsoft Office. • Proven organisational skill & high level of self-motivation. • Willingness and availability to travel on company business as required.

1416 days ago