BSI Group

  • Technical Manager - MDSAP

    Location(s) US-VA-Herndon
    Category
    Compliance & Risk
    Contract Type
    Perm Full-Time
  • About the Role

    Maintain BSI Americas Medical Devices IMDRF Medical Devices Single Audit Program (MDSAP) Auditing Organization status and support the Global MDSAP Technical Manager, Medical Devices on MDSAP compliance and regulatory issues, both internal and external. Provide the lead point of contact for the Americas with the MDSAP regulators as requested by the Global MDSAP Technical Manager, Medical Devices. Responsible for assisting with the communication to external parties (customers/Regulators / stakeholders) to support the Global MDSAP Technical Manager, Medical Devices. Assisting the Global MDSAP Technical Manager, Medical Devices being the voice of BSI on MDSAP issues in the Americas, directly speaking at external meetings and conferences in the Americas when requested by the Americas Sales and Marketing function, also ensuring BSI Americas staff deliver consistent accurate messages to local markets

    Manage the technical aspects of the MDSAP initiative in the Americas enduring that the requirements of the BSI Global procedures and processes are implemented within the Americas. Assist the Global MDSAP Technical Manager with the development and implementation of the policies, procedures and documentation required for the effective implementation of the MDSAP Scheme in the Americas.

    Provide Medical Device MDSAP expertise, leadership, mentoring and training to the relevant BSI Americas personnel. Lead the BSI Americas implementation of MDSAP and transition of CMDCAS and other existing clients into the MDSAP scheme. Assist the Global MDSAP Technical Manager in the implementation of training programs to BSI Americas staff on MDSAP auditing and align processes as far as possible with Global Medical Device assessment procedures. Utilize the Global processes for staff to demonstrate necessary competencies to deliver high quality MDSAP assessments services. Oversee technical delivery of MDSAP processes, including quotations and audits for the Americas. Act in a ‘Technical Sales Support’ capacity for MDSAP for the Americas local commercial team. The position is Herndon based and will involve regular travel within the Americas for business and representative meetings.

     

    Responsibilities:

    • Lead and manage the BSI Americas MDSAP initiative
    • Lead the Americas teams to deliver a robust and responsive MDSAP service to Americas BSI Healthcare clients
    • Work with staff across BSI Americas to roll-out the MDSAP training and qualification program
    • Work with Sales and Marketing staff to support MDSAP within the Americas auditors accounts that maintain the necessary impartiality
    • Interface with QMS Assessors scheme managers on problem and challenging accounts
    • Assist in Monitoring Americas resource / delivery of MDSAP audits
    • Liaise with the Americas regulatory function to provide technical leadership for the certificate decision Activities to ensure that the appropriate technical expertise is available to undertake certification decisions for the MDSAP Program in the Americas.
    • Provide MDSAP assessment expertise, leadership and mentoring in areas of competence to personnel in the BSI Americas medical devices stream
    • Provide advice and support to Americas QMS Assessors, operations Management on MDSAP audits and certifications in area of expertise that may have a regulatory challenge Support the Commercial Team in the Americas by ensuring responses in a timely fashion to quote requests and provide appropriate ‘Technical Sales / Networking’ support
    • Ensure consistent audit practices in the Americas for MDSAP; attend assessments as auditor or witness and provide expert briefing in complex cases
    • Provide prompt reporting back from external meetings with third parties and effective handling of issues that arise

    About You

    This great opportunity for an ambitious professional to gain visibility within the organization. We seek someone who meets all of the following criteria:

    • Annual business financial KPIs
    • Operational KPIs - Delivery of MDSAP assessment services by the Americas Teams
    • Internal training program success with a functioning and transparent training and qualification program in place
    • Positive relationship with local management colleagues maintained as service develops
    • Personally deliver an annually specified number of MDSAP audit days
    • Undertake the required Qualifying reviews for MDSAP auditors in the Americas
    • Undertake a monthly agreed number of MDSAP certification reviews

     

     

    About BSI

    Our ambition is to be recognized and valued globally as a best-in-class company; a client-driven, efficiently-run, growing business.  BSI has come a long way since being founded in 1901. Today, we’re a global business services organization, respected world over for the development of standards; assessment of management systems; testing and certification of products and services; providing software solutions; and the delivery of training courses. We offer diverse career paths from auditing to sales, product development to finance, and from IT to marketing.

     

    With Over 3,300 employees’ working with over 80,000 clients in 172 countries it means that career opportunities are vast. BSI challenges mediocrity and complacency to help embed excellence into the way people and products work. That means showing businesses how to improve performance, reduce risk and achieve sustainable growth.

     

    Our Vision: “Making excellence a habit”, it describes our way forward and our aspiration each day.

    Our Mission: “To help organizations embed excellence”, and states our shared purpose.

    Our Values: “Integrity – Continual improvement – Inclusivity”, guide us in the way we work and help us deliver our Vision and Mission.

     

    What we offer:

     

    BSI offers a competitive salary, group-sponsored health and dental, short-term and long-term disability, a company-matched 401k plan, company paid life insurance, 11 paid holidays and 4 weeks paid time off.

     

    BSI is an Equal Opportunity Employer and we are committed to diversity.

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