• Senior Regulatory Affairs Communications Specialist – Post Market (Adverse Event Reporting & Field Actions)

    Requisition ID
    2019-6884
    Job Location(s)
    Limerick Ireland
    Company
    Cook Ireland
    Position Type
    Full Time
    Category
    Regulatory Affairs
    Education
    Bachelor's Degree
  • Overview

    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  

     

     

    Find out more about Cook Medical here

    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, 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.

     

    Qualifications

    • 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.

     

    About Cook Medical

    Since 1963, Cook Medical has been finding solutions to improve the world’s healthcare problems for the patients and doctors we serve. As one of the world’s largest private companies, we have always operated with our patients, customers, employees and communities at our core. We do this, not only because it is good business, but also because we believe that being a good corporate citizen is the right thing to do.

     

    Cook Medical has been in Limerick since 1993. Since opening, we have become a European headquarters for many of Cook’s business functions.

    With a global workforce of 12,000, we employ over 850 people in Ireland who bring Endoscopy, Urology and Peripheral Intervention products from conception to commercialisation.

     

    Regulatory in Limerick

    Our RA team in Limerick are responsible for global regulation in over 60 countries, managing pre- & post- market regulation for all product classifications and novel devices across EMEA, AMER and APAC.

     

    Working cross functionally with clinical, quality and engineering during the design process and throughout the device lifecycle, RA are involved in a broad range of activities including marketing authorization and submissions, vigilance and adverse event reporting and clinical evaluation. Our Regulatory Affairs team are central to holding Cook to the highest standards because everything we do has an impact on someone’s life.

     

    Our employee benefits include:

    • Life Assurance and Income Protection cover
    • Educational Assistance
    • Company sponsored Defined Contribution pension scheme
    • Medical Health Insurance cover for you and your immediate family
    • Extensive health & wellness program including Indian head massages, healthy lifestyle seminars, mindfulness courses, physio sessions, flu vaccinations, nutrition talks
    • Fully equipped gym on site
    • 39-hour week with flexible start & finish times
    • Paid time off to participate in volunteer activities
    • Free parking
    • Subsidised restaurant
    • Sports & Social club

     

     

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