Insulet Corporation

  • Senior Director Quality Assurance & Regulatory Affairs, Europe

    Job Locations UK-London | UK-London
    Posted Date 3 months ago(2/6/2019 5:54 AM)
    Category
    Quality Assurance / Quality Engineering
  • Position Summary

    The Head of Quality Assurance & Regulatory Affairs Europe will provide overall leadership, strategy, and management for the development and execution of all European regulatory/clinical and quality assurance strategies for the progression of medical devices from R&D to clinical trials and through the regulatory process for final market approval and maintenance of new medical device products in Europe. This position serves as the European Representative.

    Responsibilities

    • Initiate and influence the business strategy by conceptualizing and driving innovative approaches that are aligned with the business needs and goals that will help us achieve necessary market approvals in Europe.
    • Provide both strategic leadership and tactical direction to support growth
    • Serve as the subject matter expert for all European regulatory, clinical and quality communications including advertising and promotion materials as well as with our European regulatory agencies and clinical partners.
    • Ensure that company policies, procedures, documents and practices are in full compliance with all appropriate regulatory, clinical and quality requirements.
    • Enable and influence business strategy by conceptualizing and driving innovative approaches to the design, plan and execution of strategies aligned with our business needs.
    • Develop, gain consensus and execute a clear regulatory vision including; strategic planning and activity with respect to regulatory requirements and the submission of regulatory documents to achieve market approvals with European regulatory authorities.
    • Be accountable for talent acquisition and development for the European Quality Assurance and Regulatory Affairs department, and to create and sustain a strong talent pipeline to meet current and future needs of the business.
    • Performs other duties as required.

    Education and Experience

    • Bachelor’s degree in a scientific or technical discipline is required.  An advanced degree is preferred.
    • Minimum of 12 years of experience in regulatory, clinical and quality coupled with 7 plus years of management experience and/or equivalent combination of education and experience.
    • Related experience within the medical device field or other regulated industry is required.
    • Prior experience taking products through the complete regulatory cycle from development through launch in Europe is required. 

     Skills/Competencies:

    • Excellent interpersonal, written communication and influencing skills are required.
    • Strong commercial orientation, along with the ability to make sound decisions with reasonable foresight as to potential risks and desired outcomes.
    • Strong strategic and tactical planning and implementation capabilities are required.

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