This role offers real diversity and variety, building, controlling and managing a portfolio of Medical Device CE marking schemes focused around your area of expertise. In addition to reviewing and evaluating medical device technical documentation you could also be undertaking Medical Device QMS assessments or advising and mentoring colleagues in your areas of competence. Strong inter-personal communication and project management skills are at the heart of this role as you work on a daily basis with manufacturers as they plan and execute their conformity assessment projects.
To be successful in this role you will need to apply the significant knowledge and extensive ‘hands on’ experience that you have gained in research, design and development of medical devices, including the application of the principles of design control, risk management and performance or clinical evaluation. The right candidate will have demonstrated strong inter-personal and communication skills, as well as a track record in project or programme management.
The role requires you to have extensive experience in the design, development and manufacturing of woundcare devices which includes one or more of the following technologies: films, gels, textile, hydrogels, creams, hydrocolloids, foams, silicone, super absorbers, haemostats, extra cellular matrices and composite dressings.
You may also have experience with wound closure technologies including sutures, clips or surgical sealant and you’ll hold a BSc, Master’s degree or PhD (or equivalent qualification) in a discipline relevant to medical device manufacture and use.
What we offer:
We offer a highly competitive starting salary (depending on experience and location) plus 10% bonus.
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.
Do you believe the world deserves excellence?
BSI (British Standards Institution) has over 81,000 clients in 180 countries, and is an organization whose standards inspire excellence across the globe. BSI Medical Devices Notified Body provides rigorous CE and ISO 13485 certification to manufacturers globally. The team apply their knowledge to 3rd party conformity assessment of all types of medical devices; active devices, active implantable devices, in vitro diagnostic devices, orthopaedic and dental devices, vascular devices, wound care devices and many others. The team has doubled in size over the past eight years, demonstrating the company’s desire to succeed and deliver world beating results. There are exciting opportunities for further growth of the Medical Devices team.
Due to continuing strategic growth within our Medical Devices business, we currently have vacancies for Technical Specialists within the General Devices team. This is an excellent opportunity to join a leading Notified Body, driving up the standard of safety and performance of Medical Devices for patients across Europe, and to be involved in the evaluation of cutting edge innovation and state of the art technologies.
We currently have an exciting opportunity in our Medical Devices department, working as a Woundcare Technical Specialist within the General Devices Team. This is a home based role which could be carried out remotely across the US.