The BSI Group have an exciting opportunity in Medical Devices Notified Body working as a Technical Specialist within the Active Implantable Medical Devices (AIMD) Team. This role can be a home based role or office based across Europe ideally in the UK, France, Switzerland or Italy.
- An understanding of companies operating in these spaces and current industry trends.
- You’ll be able to demonstrate a broad technical understanding of Active Implantable Medical Devices and have hands-on experience of design, manufacture or testing in the AIMD industry, or clinical application of active implantable devices.
- An appreciation of risks related to implanted materials.
- An appreciation of risks related to use of software in critical applications.
- Knowledge of Medical Device regulations and QMS systems for medical devices.
- An understanding of Risk Management and FMEA for active implantable devices.
- Conceptual and analytical thinking, efficiency and results orientation.
- Interpretation and applications of International and National standards for the design, manufacture and regulation of medical devices.
|Location||Europe – Home-based|
|Salary||Up to £65,000 plus 15% bonus|
- Deliver AIMD, Medical Device and R&TTE CE Technical Assessment services either from the office or on-site as a fully integrated member of the AIMD Team
- Perform Unannounced visits to manufacturers globally as a technical expert
- Deliver all services within required timescales and to a high quality
- Work with Line Manager and other team leaders as required to provide reviews within area of expertise
- Maintain client satisfaction whilst continuing to meet BSI’s ethical expectations
- Perform in-house and external training to colleagues and clients
Closes Tuesday, 5 January 2016
BSI (British Standards Institution) is the business standards company that equips businesses with the necessary solutions to turn standards of best practice into habits of excellence. Renowned for its marks of excellence including the consumer recognized BSI Kitemark™, BSI’s influence spans multiple sectors including Aerospace, Automotive, Built Environment, Food, Healthcare and ICT. With over 80,000 clients in 170 countries, BSI is an organization whose standards inspire excellence across the globe.