• 14 Danville Business Park, Kilkenny, R95 F727, Ireland
  • +353 56 779 0100
  • info@prochem.ie
  • North Valley Business Centre, Cork, T23 KC67, Ireland     +353 21 206 6178     info@prochem.ie
  • Senior Regulatory Affairs Specialist – Co. Waterford

    Role Purpose:


    • Our client is looking for a Senior Global Regulatory Affairs Specialist (Medical Devices – Post Market) to join their busy site in Co. Waterford.
    • The Senior Global Regulatory Affairs (GRA) Specialist will independently support all regulatory medical device initiatives for post-market/lifecycle management aspects of the company’s respective product families.
    • The successful candidate is responsible for implementing the regulatory post-market strategies of all submissions for products under their responsibility, as well as managing interactions with regulatory authorities on post-market issues.


    Core Duties and Responsibilities:


    • Implement and manage post-market regulatory strategy for marketed devices with a focus on maximizing the business benefit balanced with regulatory compliance.
    • Proactively communicate the post-market regulatory strategy, key issues, and any other critical topics throughout the post-market lifecycle to interdisciplinary project teams and to appropriate management levels in Global Regulatory Affairs, R&D, Engineering and Supply Chain, as appropriate in a timely manner.
    • Lead and manage all post-market submission activities which include but are not limited to planning, compiling, authoring, reviewing, and coordinating the submission/notification.
    • Make quality regulatory decisions, balancing risks and benefits.
    • Identify as early as possible the required documentation and any content, quality and/or timeline issues for projects.
    • Negotiate the delivery of approved technical source documents in accordance with project timelines.
    • Coordinate with Regulatory Operations to ensure timely and accurate submissions to Regulatory Authorities.
    • Support or manage interactions with regulatory authorities on post-market issues.
    • Provide regulatory support to all departments during Regulatory Authority inspections/audits.
    • Serve as a Regulatory Affairs representative on facility/site Local Change Management Boards.
    • Review and provide input on regulatory authority guidance documents.


    Education & Qualifications Required:


    • 5+ years of Medical Device (or similar area) regulatory experience
    • Knowledge of medical device industry Regulatory Affairs post-market/lifecycle management discipline, with awareness of commercialization and operations.
    • Capability to react quickly to changes in the regulatory environment and make strategic recommendations to minimize risk to the business.
    • Ability to interpret Regulatory Authority policies and guidance’s and correctly apply them, as appropriate in post-approval/clearance activities.
    • Demonstrated ability in analytical reasoning and critical thinking skills.
    • Strong capability to contribute to a team environment.
    • Excellent communication skills; both oral and written.
    • Self-motivated, detail-oriented and capable of working independently.


    To Apply: Quote – PE23065


    If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:

    14 Danville Business Park, Kilkenny, R95 F727, Ireland.
    +353 56 77 90100

    Click here to submit your CV

    Please note, we do not require agency assistance with this role.