• Regulatory Affairs Specialist

    Requisition ID
    2019-7136
    Job Location(s)
    Limerick Ireland
    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 Regulatory Affairs Specialist helps develop regulatory strategies, performs activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets. The regulatory affairs specialist serves as a communication liaison between the Cook manufacturer and the Cook local affiliates or regulatory authorities.

     

    Reporting to: Regulatory Affairs Manager

    Responsibilities

    • Maintain an excellent understanding of global medical device regulations for specific jurisdictions as assigned such as regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA QSP 21CFR Part 820 as required.
    • Ensures a thorough understanding of the products they are assigned.
    • Communicates country/region specific regulatory requirements to the regulatory specialists/ managers.
    • Develop 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.
    • Ensure the outputs from the individual functional units meet the applicable regulatory requirements.
    • Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations as required.
    • Maintains registration information (license numbers, expiration dates etc) and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability.
    • Ensures the biocompatibility requirements of the product are adequately addressed.
    • Communication of the clinical requirements for regulatory registrations for the product and working as part of a cross functional team to ensure that they are adequately addressed.
    • Communicates directly with notified bodies and other regulatory authorities to ensure product approvals are achieved in a timely manner.
    • Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required.
    • Serves as a liaison on regulatory issues between the Cook Manufacturer and the Cook International local office and/or Cook distribution partner.
    • Provides support to currently marketed products as necessary including input on change requests, etc.
    • 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.

    Qualifications

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

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed