• Senior Specialist, Regulatory Affairs

    Requisition ID
    2019-7072
    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 role of the Senior Specialist, Regulatory Affairs is to assist in the running of the Regulatory Affairs (RA) function. The Senior provides technical input into: regulatory strategies, performing activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets. Provides regulatory affairs support for the functional areas and input into regulatory strategies on behalf of Cook Medical.

     

    Reporting to: Regulatory Affairs Manager

     

     

    Find out more about Cook Medical here

    Responsibilities

    • Assists in the running of the Cook Ireland regulatory affairs programs in line with internal procedures and in accordance with regulatory requirements. ISO13485, MDD 93/42/EEC, EU-MDR 2017/745 and FDA 21CFR Part 820, and other jurisdictions as required.
    • Maintains an excellent understanding of the global medical device regulations related to Class 2a, 2b, 2b implantable and Class 3 Drug Device products and how these regulations apply to Cook Medical products.
    • Maintains an excellent understanding of the applicable standards, harmonised, ISO, ASTM etc related to the Cook Medical products.
    • Highlights any updates to regulatory requirements with regulatory management and works with the applicable stakeholders to develop a strategy to implement any subsequent changes.
    • Develops global regulatory strategies for Cook medical devices in collaboration with other regulatory affairs or clinical personal, especially on high-risk devices.
    • Advises other Cook functional units (engineering, marketing, operations, quality etc) of the requirements in each target market and update same on approval status in target markets.
    • Works with other Cook functional units (engineering, marketing, operations, quality etc.) to ensure that the relevant documentation (Design Reviews, Process qualifications, Protocols and reports etc.) are adequate to meet the relevant regulatory need.
    • Provide subject matter expertise and guidance related to applicable regulatory requirements, including but not limited to Clinical evaluation reports (CER MEDEV 2.7.1 Rev 4), Post Market surveillance (Post Market Clinical
    • Follow Up and Periodic Safety Update Reports), Design Dossiers, Risk Management Files, Biocompatibility, Sterilisation and Product Labelling.
    • Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations as needed.
    • Liaise and negotiate with the Notified Bodies, Competent Authorities, FDA etc. to ensure that planned actions will satisfy the regulators expectations.
    • Coordinates multiple projects and communicates status of projects/submissions directly to RA Management and other stakeholders as required.
    • Act as a liaison on regulatory issues between the Cook Manufacturer and the Cook International local office and/or Cook distribution partner.
    • 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 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 in Science/Quality preferred.
    • 5 years’ + experience in a regulated industry in a similar role is desirable.
    • Knowledge of requirements in GHTF countries including regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU-MDR 2017/745 and FDA 21CFR Part 820
    • Knowledge of requirements in other jurisdictions.
    • Knowledge of medical device quality standards/practises or similar regulated industry.
    • Good communication and inter-personal skills.
    • Proven problem-solving, prioritisation & organisation skills.
    • Good computer skills including knowledge of Microsoft®

     

    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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