• Certification Lead

    Location(s)
    NL-Amsterdam
    Category
    Healthcare
    Contract Type
    Perm Full-Time
    Salary
    Competitive Salary plus Bonus
  • The Opportunity

    We currently have an exciting new opportunity in our Medical Devices Notified Body team in the Netherlands, working as a Certification Lead. This role can be home based or based in our Amsterdam office.

     

    In this role you'll play a vital role in supporting the Global Medical Devices Scheme Manager & Technical Specialist Team to deliver certification recommendations, monitoring of technical documentation reviews and competence verification in support of ISO 13485, CE marking and related medical device scheme including the delivery of procedures and forms that meet regulatory requirements and associated Internal Training.

     

    You'll also provide Medical Device expertise leadership and mentoring in CE Marking, input and expertise to new projects and requirement

     

    Your role will involve some travel to BSI and third party locations around the globe for training, business and representative meetings or audits.

    About BSI

    Do you believe the world deserves excellence?

    BSI (British Standards Institution) has over 81,000 clients in 180 countries, and is an organization whose standards inspire excellence across the globe.   BSI Medical Devices Notified Body provides rigorous CE and ISO 13485 certification to manufacturers globally.  The team apply their knowledge to 3rd party conformity assessment of all types of medical devices; active devices, active implantable devices, in vitro diagnostic devices, orthopaedic and dental devices, vascular devices, wound care devices and many others. The team has doubled in size over the past eight years, demonstrating the company’s desire to succeed and deliver world beating results.  There are exciting opportunities for further growth of the Medical Devices team.   

    About You

    To succeed in this role you'll have a comprehensive understanding of technical documentation required by the manufacture of medical devices including the applicable regulations and standards along with thorough knowledge of Medical Device QMS standards and regulations.


    You'll have a good understanding of product and QMS certification concepts and principles and a comprehensive understanding of quality systems, philosophies and principles and internal auditing principles and practices.in order to provide expertise to the teams.


    In addition you'll have a good understanding of the application of accreditation/designation, notified body, product and quality systems standards and requirements

     

     

    What we offer:

    We offer a highly competitive starting salary plus bonus.  BSI also offers employees a wide range of flexible benefits that you can tailor to suit your life-style.

     

    We pride ourselves on setting the industry benchmark and invest significantly in our teams to ensure that our people have the best possible opportunity to deliver an excellent service and progress their careers.  As the successful candidate, you will embark on a comprehensive induction into the role and will be supported in a continuous professional development programme.

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