• Senior Regulatory Affairs Specialist

    Requisition ID
    2019-6217
    Job Location(s)
    Limerick Ireland
    Travel
    None
    Company
    Cook Ireland
    Position Type
    Full Time
    Category
    Regulatory Affairs
    Education
    Bachelor's Degree
  • 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 primary role of the Senior Regulatory Affairs Specialist is lead a team & manage projects, providing input into: regulatory strategies, performing activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets and providing regulatory affairs input for the functional areas.

     

    Reporting to: Regulatory Affairs Manager

     

     

    Find out more about Cook Medical here

    Responsibilities

    • Assists in the running of the Cook Ireland regulatory affairs programmes in accordance with internal procedures and regulatory requirements.
    • Responsibility for assisting in implementing regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA 21CFR Part 820 as required and other jurisdictions as required.
    • Works to improve the function of the Regulatory Affairs Department.
    • Supports the progress of direct reports on assigned tasks, and provides advice on the removal of roadblocks.
    • Mentors and train new regulatory team members.
    • Highlights any updates to regulatory requirements to regulatory management.
    • Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations as needed or collaborates with their assigned regulatory specialists on same.
    • Reviews submissions generated for their assigned regulatory area to ensure compliance to the regulations in that particular jurisdiction.
    • Develops global regulatory strategies for Cook medical devices in collaboration with other regulatory affairs or clinical personal (as applicable), especially on high risk devices.
    • Advise other Cook functional units (engineering, marketing, operations, quality etc) of the requirements in each target market and updates same on approval status in target markets.
    • Ensures the biocompatibility requirements of the product are adequately addressed.
    • Ensures the clinical requirements of the product are adequately addressed.
    • Ensure the outputs from the individual functional units (engineering, marketing etc.) meet the applicable regulatory requirements.
    • Communicates status of projects / submissions directly to RA Management and other stakeholders as required.
    • Communicates directly with regional regulatory agencies / notified bodies to ensure product clearances are achieved in a timely manner.
    • Serves as a liaison on regulatory issues between the Cook Manufacturer and the Cook International local office and/or Cook distribution partner.
    • Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required.
    • Maintains a system for registration information (license numbers, expiration dates etc) and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability.
    • Provides support to currently marketed products as necessary including input on change requests, etc.
    • Maintains an excellent understanding of the global medical device regulations.
    • Maintains a thorough understanding of the products assigned to the team.
    • Maintains and organises appropriate regulatory records to demonstrate compliance with applicable regulations.
    • Provides regulatory support to Cook functional units such as the SSC, tenders, customer quality and distribution.
    • Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.

    Qualifications

    • Third level Qualification preferably in Science/Quality, 5 years’ experience in a regulated industry in a similar role is desirable.
    • Ideally have knowledge of requirements in GHTF countries including regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA 21CFR Part 820 as required.
    • Knowledge of requirements in other jurisdictions where required.
    • Knowledge of medical device quality standards/practises or similar regulated industry.
    • Good communication and inter-personal skills.
    • Proven problem-solving skills.
    • Good computer skills including knowledge of Microsoft ® Office.
    • Proven organisational skills.
    • High self-motivation.
    • Approved External Auditor.
    • Willingness and availability 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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