Leadership, Quality and Regulatory Expertise for Growing Med Tech Organizations

Our mission is to build strong partnerships with leaders and organizations, engaging in close collaboration to meticulously plan, expertly develop, and seamlessly execute custom business, regulatory, compliance, and quality strategies.

With a relentless focus on innovation, integrity, and excellence, we partner with our clients to navigate complex quality and regulatory challenges, achieve regulatory compliance, and drive predictability in the changing regulatory landscape.

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Empowering Your Business Success

We specialize in delivering comprehensive organizational design, quality, and regulatory solutions that are seamlessly aligned with the unique needs and developmental stages of each of our clients. From inception to maturity, we offer expertise across the entire product lifecycle, ensuring quality regulatory compliance solutions and optimized operational performance at every phase.

  • Leadership & Business Strategy Support

    Partnering with organizations to provide fractional leadership, develop and implement strategy that builds business processes and maximizes organizational productivity, and support efficiency and business readiness for scalability.

  • Quality Strategy & Regulatory Solutions

    Supporting organizations of all sizes and at all phases of the product development lifecycle to establish, implement and/or optimize their Quality Management Systems and regulatory frameworks to ensure audit readiness and product, quality and regulatory excellence.

  • Quality & Regulatory Training

    Customized courses focused on the fundamentals of a Quality Management System and regulatory framework as defined by the client's needs, its stage of product development and company size.

  • Executive Coaching & Mentoring

    Leveraging my 20+years in leadership roles, I am passionate about working with business and thought leaders to develop a plan to help achieve their career goals and aspirations.

    • About the Founder

    Jennifer Mascioli-Tudor is an experienced leader, who brings more than 20 years of industry experience in Quality and Regulatory leading global teams within the pharmaceutical and medical device industries. She has an extensive background in leadership and global quality assurance, regulatory affairs, and operational excellence.

    Jennifer has progressed through several roles of increasing leadership responsibility working for companies such as Johnson and Johnson, Medtronic, Nevro, American Medical Systems, Boston Scientific, Outset Medical and GE Healthcare. She is passionate about building energized, diverse and inclusive teams and driving efforts around process optimization and continuous improvement.

    She started JMT Compliance Consulting to work with organizations to drive Quality, Regulatory and Organizational excellence across the medical device and other complimentary industries.

    She holds a B.S. in Physiology/Chemistry and French from Eastern Michigan University and an M.B.A. from the University of Phoenix. She was born and raised in a small Northern Ontario town in Canada and now lives in Mountain View, California with her husband and two kids.

    EDUCATION AND CERTIFICATIONS

    • International Association of Professions Career College (IAP Career College): Executive Coach Certification
    • Management and Strategy Institute: Six Sigma Black Belt Professional Certification
    • MBA, Emphasis in Global Management, University of Phoenix
    • B.Sc., Physiology/Chemistry/French (fluent in both writing and speaking), Eastern Michigan University

    PROFESSIONAL MEMBERSHIPS AND ASSOCIATIONS

    • UC San Diego: Instructor, Overview of Regulatory Affairs for Medical Devices & Design Control for Medical Devices
    • Women’s Unlimited (Mentor): Developing women leaders who deliver results
    • DxD Health Tech (Mentor): Foster diversity, equity & inclusion in the healthtech industry
    • American Society for Quality (ASQ) Member
    • Regulatory Affairs Professional Society (RAPS) Member

    Let's Start a Conversation

    As a first step, schedule a call with Jennifer to share more about the needs of your company and discuss potential next steps.

    Schedule a call