Position Overview & Specifications
** Home Office Opportunity ** Product Expert (Active devices)
Introduction
One of the world’s largest Notified Bodies, headquartered in Germany and with entities all over the globe is currently searching for experts with experience in the field of Pacemakers or similar products to join them as a Product Expert.
This role will offer you
· Opportunity to work with a well known Medical Device Notified Body
· Work daily with some of the largest and most innovative Medical Device companies globally
· Gain experience working with a wide range of new & Innovative Medical Devices
You will be responsible for
- You evaluate highly complex medical devices and the associated documentation according to the relevant technical regulations and relevant EC directives.
- As a product expert (f/m/d), you will assess medical devices and medical device manufacturers as well as product documentation on the basis of applicable regulations and international standards.
- The creation of compliant documentation on medical devices ranks your field of activity.
- As the first point of contact, you act as a certifier and/or specialist certifier if necessary.
- You carry out evaluations in one or more subject areas such as, Clinical evaluation of highly complex medical devices, Interactions between medical devices and medicinal products, BSE/TSE risk assessment including depletion procedures, Evaluation of highly complex medical devices / systems (e.g. linear accelerators, surgical robots, microsurgical systems) including software, Biocompatibility assessments for critical or new materials or applications that are included in this In this context, it is important to stress the importance of the role of the social partners in the development of the European Union's external relations (e.g. nanotechnology) or radiation.
You will bring the following
· Minimum Bachelors Degree in Engineering, Biochemistry, Chemistry, Biotechnology Etc
· Extensive Experience in Active implants in Medical Devices
· Good understanding of Quality Standards in the Medical Device space (ISO13485, MDD, MDR, MDSAP)
· German speaking
BioTalent Ltd are acting as an employment agency in relation to this opportunity.
Gehalt: £50.000,00 - £70.000,00 pro Jahr
Arbeitsort: Homeoffice