• Regulatory Affairs Associate

    Requisition ID
    2018-4865
    Job Location(s)
    Limerick Ireland
    Languages Required
    English
    Travel
    Less than 10%
    Company
    Cook Ireland
    Position Type
    Full Time
    Category
    Regulatory Affairs
    Education
    Associate's Degree/Diploma, Bachelor's Degree
  • Overview

    The regulatory affairs associate assists in the implementation of regulatory strategies, performs activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets. The regulatory affairs associate serves as a communication liaison between the Cook manufacturer and the Cook local affiliates or regulatory authorities.

    Reporting to: Senior Regulatory Affairs Specialist

    Find out more about Cook Medical here

    Responsibilities

    • Obtains and maintains an understanding global medical device regulations for specific jurisdictions as assigned such as regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA 21CFR Part 820 and become proficient / knowledgeable in global medical device regulations.
    • Develop a thorough understanding of the medical devices they are assigned.
    • Assist in the implementation of global regulatory strategies for Cook medical devices in collaboration with other regulatory affairs or clinical personal (as applicable), on all classes of devices.
    • Plans and prepares regulatory submissions for specific target markets for new products, product changes and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability.
    • Maintains registration information (license numbers, expiration dates, regulatory logs for annual reports, filing / printing of regulatory submissions, correspondence etc).
    • Perform and maintain global regulatory restrictions in accordance with marketing authorizations.
    • Communication with Cook Sister Companies, Distribution Partners and Regulatory Authorities to ensure product approvals 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.
    • Working with other functional units / departments in assessing changes to medical devices, determination of regulatory impact and communication to regulatory management.
    • Assistance in procedure updates where required; circulation of change requests
    • Organizing documentation notarization, legalization / apostille with notary, Department of Foreign Affairs and relevant Embassies as appropriate for global registrations.
    • 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.
    • Assist Regulatory Reporting / Communications as required with the following duties:
    • o Assess complaints from Cook global distribution centres for adequate information to determine if event meets Regulatory Reporting requirements.
    • o Utilize appropriate complaint software systems for processing complaints to/from distribution centres and QE Investigation functions.
    • o Peer review of regulatory assessments as necessary.
    • o Generate appropriate regulatory reports based on assessment.
    • o Liaise effectively with regulators on all issues with regard to regulatory reporting.
    • o Ensuring that confirmed reportable events are escalated to the appropriate personnel in a timely manner.
    • o Communicate with other Cook Companies globally as necessary for reporting.
    • o Generate responses to inquiries on AE reports from various global regulatory authorities.
    • o Generate various reports, including but not limited to, Regulatory requests, Marketing requests, Engineering requests.
    • o Assist in coordination of Recall administration activities between manufacturer and distribution centre.
    • o Close out of complaints as necessary.  
    • Performs additional duties as assigned.

    Qualifications

    • Third level Qualification in Science/Engineering is desirable.
    • At least 1 year experience in a regulated industry preferable but not essential.
    • Basic knowledge / interest in Regulatory Affairs.
    • Basic 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.
    • Willingness to travel on company business when required.

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