Salary: Negotiable €60-80K
Training: Yes (Full).
We currently have an exciting opportunity in our Medical Devices Notified Body working as a Technical Product Specialist within the Active Medical Devices Team.
As a dedicated Technical Specialist you will be responsible for reviewing the design dossiers of a wide range of Active Medical devices with the aim of determining whether the devices meet the requirements of the Active Medical Devices Directive and relevant harmonised standards. You will write comprehensive audit reports which either support or reject the manufacturers application for CE marking based on the evidence provided. Ultimately your work will determine whether or not a device has been demonstrated to be safe and effective, meets its intended use and can be awarded CE certification.
- Deliver Active, Medical Device and R&TTE CE Technical Assessment services either from the office or on-site as a fully integrated member of the Active MDD Team.
- Perform Unannounced visits to manufacturers globally as a technical expert.
- Work with Line Manager and other team leaders as required to provide reviews within area of expertise.
- Deliver all services within required timescales and to a high quality.
- Maintain client satisfaction whilst continuing to meet BSI’s ethical expectations.
- Perform in-house and external training to colleagues and clients.
- Maintain competence in their area of technical expertise and Active Devices, Medical Devices and R&TTE certification.
- Strong project management skills are essential as you will manage your own work load, be responsible for ensuring that reviews are delivered within agreed timescales and that your time is booked and charged appropriately.
To be successful in this role you will be educated with a BSc degree or PhD in a discipline relevant to design and manufacture, or equivalent qualification and have a minimum of 5-10 years’ experience in the design and development of medical devices:
You will be able to demonstrate:
- A broad technical understanding of Active Medical Devices.
- An understanding of companies operating in these spaces and current industry trends.
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- Medical Devices
- Product Development
- Medical Device Directive
- Product Specialists
- Scientific Background
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