As a Notified Body under the Medical Device Directives, BSI has the technical expertise and experience to provide CE marking services to medical device manufacturers.
Now is a great time to join BSI and become part of team that is passionate about quality, technology, and patient safety.
We are seeking home-based Technical Specialists for our Active Devices team to manage a portfolio of 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 interpersonal 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.
This position is intended for highly technical and experienced professionals that have hands-on engineering experience working for medical device manufacturers as well as demonstrated interest in the regulatory side of the Medical Device Industry.
What We Offer : Competitive base salary plus 10% annual bonus Generous paid time off and paid holidays 401k with employer match Medical, Dental, Vision, and Life Insurance plus Short and Long-term Disability Coverage
Do you believe the world deserves 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, Medical Devices and ICT.
With over 80,000 clients in 172 countries, BSI is an organization whose standards inspire excellence across the globe.
Job Requirements : Bachelor’s degree in a discipline relevant to medical device manufacture and use Thorough knowledge and at least five (5) years of experience in the design and development of active medical devices, including the principles of design control, risk management and performance or clinical evaluation Experience in electro-
medical device technical development or testing & at minimum an awareness of the requirements of IEC 60601 Third Edition and the risk management standard ISO 14971.
Thorough knowledge of Medical Device regulations, ISO 13485 and have a broad technical understanding of the medical device industry.
Excellent written and verbal English communication skills Ability to travel 25% for trainings, team meetings, and client visits In addition, you will : Have a conceptual and analytical way of thinking, be efficient and results orientated Be a team player good at relationship building internally and externally