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;
Do you believe the world deserves excellence?
BSI (British Standards Institution) Medical Devices Notified Body provides CE and ISO 13485 certification to manufacturers globally. The team also apply their knowledge to 3rd party conformity assessment of all types of medical device; active devices, active implantable devices, in vitro diagnostic devices, orthopaedic and dental devices, vascular devices, woundcare devices and many others. The team has doubled in size over the past eight years. There is opportunity for further growth of the Medical Devices team.
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.