• CMEU Regulatory Affairs Project Officer

    Requisition ID
    2019-7216
    Job Location(s)
    Limerick Ireland
    Company
    Cook Medical Europe Ltd
    Position Type
    Full Time
    Category
    Regulatory Affairs
  • Overview


    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.

     

    The Regulatory Affairs Project Officer carries out the Administration and Project Management duties for the Regulatory Affairs group. These duties include updating regulatory affairs databases and logs as necessary, preparing and updating regulatory affairs documents and tracking and managing projects.

    Responsibilities

    • Responsibility for structuring and updating regulatory affairs databases, files and logs.
    • Preparing and updating regulatory affairs documents and procedures.
    • Liaise with the team to ensure that deadlines are being understood and met.
    • Manage regulatory driven projects, such as identifying the scope, risks and contingency plans, deliverables and milestones.
    • Coordinates multiple projects at one time and provides regular reports to regulatory affairs as required.
    • Maintains and organises appropriate regulatory records to demonstrate compliance with applicable regulations.
    • Provide information from many internal and external sources as directed and possess tremendous perseverance both in gathering information as well as following up on specified issues.
    • Provide knowledge, awareness, and acumen for taking essential notes at multiple meetings and rapidly translating these notes into summaries, reports or into actionable steps for approval.

    Qualifications

    • Preferably with a strong Projects background, ideally involving cross-functional, multiple discipline teams;
      • Able to produce Charters, Work Breakdown Structures and Gantt charts and track projects.
      • Ability to manage or facilitate teams essential.
    • Must be highly disciplined and self-motivated.
    • Proven ability to communicate and work constructively with colleagues.
    • Excellent organizational and prioritizing capabilities.
    • Strong problem-solving skills and personal discipline.
    • Ability to succeed with close direction or independently as needed.
    • Must have superior writing, presentation and organizing skills, and be comfortable with software and equipment used for such, including Microsoft PowerPoint, Excel, and Word;
      • Microsoft Visio and Microsoft Project knowledge an advantage.
      • Accredited qualification in Microsoft® Office is preferable.
      • Advanced Excel skills would be a significant advantage.
        • Macros, formulas, pivot tables and VBA knowledge preferred.
    • Proven Administrative experience.
    • Excellent communication and inter-personal skills.
    • Availability and willingness to travel on company business.

     

    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.

     

    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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