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    Senior Manager QA - belfast, United Kingdom - CareerWise Recruitment

    CareerWise Recruitment
    CareerWise Recruitment belfast, United Kingdom

    5 days ago

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    Description
    Job Description

    A Senior Manager, QA / RA is required on a PERMANENET basis by CareerWise Recruitment for our Belfast-based multinational Medical Device Company.

    Are you ready to lead a dynamic team of regulatory and quality professionals towards excellence in ensuring market access, product quality and compliance for life-saving medical devices? In this exciting role, the Senior Manager Regulatory Affairs and Quality Assurance will oversee the HeartSine AED product portfolio (Class III medical device).

    THE ROLE:

    • Leadership: Lead and inspire a team of regulatory and quality professionals, comprising 2 managers and 3 individual contributors, towards the achievement of business strategies for the HeartSine AED product portfolio.
    • Regulatory Compliance: Monitor evolving regulations, ensuring adherence to governmental and internal standards while driving implementation strategies.
    • Strategic Planning: Develop organizational strategies and metrics to enhance regulatory and quality processes, ensuring device conformity and post-market obligations.
    • Cross-Functional Collaboration: Collaborate with various departments to align corporate goals and strategies, ensuring regulatory and quality objectives are met.
    • Budget Management: Establish and manage budgets to optimize resource allocation and support effective operations.
    • Talent Development: Recruit, onboard, and engage top talent, fostering a culture of continuous improvement and professional development.
    • Representation and Advocacy: Represent regulatory and quality processes during audits and participate in advanced advocacy activities.

    REQUIREMENTS:

    You have successfully completed a Bachelor or Master of Science, Engineering or any related discipline.

    You have 8+ years of relevant professional experience in RAQA within medical device industry, ideally with Class III products.

    Furthermore, you have experience in managing a team of direct reports including people development.

    You are ideally RAC certified (or equivalent).

    You are characterized by a high level of communication skills, strategic thinking, analytical and negotiation skills as well as extensive interface competencies.

    You enjoy working in an international and complex matrix-organization.

    Your excellent English language skills enable you to collaborate with stakeholders on a global basis.

    Please call Aisling O'Hagan-Yil today for further information on or email: aohagan-

    CareerWise Recruitment (In Search of Excellence)

    Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.

    We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

    By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

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