Senior Regulatory Affairs Communication Specialist
Ref No: SF17006
Limerick, Co. Limerick, Ireland
Senior Regulatory Affairs Communications Specialist – Post Market, Adverse Event Reporting & Field Actions- Limerick
A large Medical Device Manufacturer is recruiting a Senior Regulatory Affairs Specialist to assist with the running of the Regulatory Affairs team by ensuring that the EMEA registrations, regulatory communications, Post Market Surveillance, Distribution Channel Management and EC Authorised Rep functions of the RA team are effective and the required regulations are implemented.
The role will be 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, 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 Manufacturer and the 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 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.
- Perform additional duties as assigned.
- Actively pursues 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.
- Ensure that Code of Conduct is considered in all business matters carried out.
Qualifications / Requirements:
- 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® Office.
- Proven organisational skill & high level of self-motivation.
- Willingness and availability to travel on company business as required.
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