• Compliance Manager - Medical Devices

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

    Do you have a comprehensive understanding of quality systems, philosophies and principles and internal auditing principles and practices?

     

    Do you want to apply your knowledge of the application of accreditation/designation, notified body, product and quality systems standards and requirements?

     

    Are you looking for a rewarding career with the world's number one Medical Device Notified Body?

     

    As a Medical Devices Compliance Manager, homebased anywhere in The Netherlands, you’ll ensure BSI achieve full compliance to accreditation/designation requirements for all Medical Devices product certification activities. You’ll be responsible for activities such as managing external audits, carrying out regular and robust internal audits, managing CAPA and concessions, carrying out certificate decisions, employee training and providing internal compliance expertise. This role can be based in our Milton Keynes office or can be homebased.

     

    Your key activities will be;

    • Providing support in the Compliance & Risk interface with the respective regulatory bodies. This includes managing the external audit process and the closure of non-conformities raised during these audits to ensure continued operation as an accredited/designated certification body.
    • Working with the business to ensure that procedures are appropriately developed and documented to ensure consistent service delivery.
    • Carrying out general internal audits and Medical Devices audits for compliance and improvement.
    • Assisting in ISO17021/17025/17065 auditing.
    • Attending as appropriate national and international regulatory events which have a bearing on BSI’s accreditation/designation status.
    • Delivering training where required to Medical Devices team.
    • Providing advice to the business in the process of developing new and revised services and products taking cognisance of the risks to the business.
    • Providing general advice and guidance to Medical Devices team on risk, legal, technical, regulatory policy and procedural issues
    • Ensuring continued compliance and continual business improvement through participation in the internal audit programme and implementation of CAPA and improvement opportunities.
    • Any other duties required to support and develop the Medical Devices Compliance & Risk Team

    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 excel in this role you’ll need to bring your understanding of product certification concepts & principles, quality systems, philosophies and principles and internal auditing principles and practices

     

    A good understanding of the application of accreditation/designation, notified body, product and quality systems standards and requirements is vital as well as thorough knowledge of Medical Device regulation worldwide and conformity assessment procedures.

     

    In addition you’ll have a comprehensive understanding of Medical Devices manufacturers’ QMS assessment techniques and hole a Degree or equivalent in a Medical Device / Life Science related subject.

     

     

    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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