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    VP of Quality Assurance & Regulatory Affairs

    Human Xtensions is an Israeli public company developing technology in the field of Minimally Invasive Surgery. We are looking for an experienced VP RA & QA, reporting directly to the CEO.

    The VP of QA & RA will lead our QA & RA department and be responsible for the quality system and regulatory activities.

    The company holds ISO 13485, MDR, and MDSAP certificates. The company’s products are already FDA-cleared and CE-approved.

     

    Responsibilities

    • Work closely alongside with company’s CEO and be part of the management team.
    • Manage the QA and RA Department and be responsible for all quality and regulatory matters across the company activities.
    • Lead, manage, and implement quality and regulatory activities in developing and implementing regulatory premarket strategies and processes to gain product approvals worldwide.
    • Develop QMS strategies, systems, and processes to ensure that Human Xtensions’ product development, manufacturing, and post-market activities comply with the regulatory requirements.
    • Ensure that the company’s Quality System complies with regulatory requirements and all applicable standards worldwide.
    • Collaborate with senior management and all functional groups at all enterprise levels to drive a culture of Quality by conceiving, collaborating, and supporting the implementation of specific actions, processes, and behaviors that support such a culture.
    • Act as a trusted advisor and business partner in balancing risk and opportunity and advise on strategic decision-making.
    • Develop a regulatory strategy in alignment with company’s overall commercial strategy.
    • Oversee the regulatory submissions in compliance with the applicable international regulatory requirements.
    • Oversee and participate in the writing, reviewing, editing, and compiling of regulatory submissions and quality documentation.
    • Provide support, mentorship, and guidance to quality assurance and regulatory affairs to ensure staff can independently make sound strategic and tactical decisions.
    • Lead Human Xtensions’ external audits (front room).
    • Act as the Person Responsible for Regulatory Compliance (PRRC).

     

    Requirements

    • Bachelor’s degree in a related field.
    • 10+ years of experience in the fields of Regulatory and Quality Assurance in the Medical Devices Industry.
    • Minimum 5 years of management experience in Quality Assurance & Regulatory Affairs.
    • Excellent knowledge of ISO 13485:2016, MDSAP, MDD, MDR.
    • Experienced in regulatory submissions to FDA, EU, and MDSAP jurisdictions for class 2 or 3 products.
    • English at a very high level – both written and verbal – Must (other languages – an advantage).
    • Hands-on approach.
    • Great attention to detail, and a result-driven approach.
    • Excellent personal & communication skills, highly motivated.
    • Excellent organizational and leadership abilities.
    •  Team player
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