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