The Senior Regulatory Affairs Communications Specialist – Post Market (Adverse Event Reporting & Field Actions) supervises and manages a team of RA specialists with responsibility for the Adverse Event Reporting and Field Action for all Cook Ireland devices.
Reporting to: Regulatory Affairs Manager
- 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, Cook Affiliates and/or Cook Distributors as required.
- Recall co-ordination (including Competent Authority responses) – Global and Local as appropriate.
- Serve as a liaison on regulatory issues between the Cook Manufacturer and the Cook Affiliates and/or Cook 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 Authorization 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 pursues ways in which to improve the function of the Regulatory Affairs Department supporting continuous improvement activities.
- Third level Qualification in Science/Quality preferred.
- 5 years’ + experience in a regulated industry in a similar role desired.
- 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®
- Proven organisational skill & high level of self-motivation.
- Willingness and availability to travel on company business as required.