Looking to take on an exciting and varied role as a Scheme Manager? Want to help drive cutting-edge innovation and work with state-of-the-art technologies? If so, we’d love to hear from you.
When it comes to medical devices, our mission is to ensure patient safety while supporting quick and easy access to medical device technology. We strive to set the global standard in thorough, responsive, predictable conformity assessments, evaluations, and certifications.
Now, we’re looking for a Scheme Manager to help us equip businesses with the solutions they need to transform standards of best practice into habits of excellence.
As a Scheme Manager, you will be responsible for the management and development of a portfolio of Medical Device CE marking and ISO 13485 schemes.
In this varied role, you will oversee assessment and certification activities, co-ordinating with the audit delivery team, as well as Technical Specialists and support staff to ensure clients’ products and quality systems comply with regulatory requirements.
You’ll provide advice to colleagues on medical device certification so they too can help clients to achieve product excellence.
- Take part in client meetings to gain a clear understanding of their businesses goals, translating these in to regulatory requirements and ultimately determining assessment needs
- Review and approve quotations, conduct contract reviews, and process applications
- Review assessment reports to determine whether a recommendation for certification can be justified
- Compile certification decision files for activities such as initial approvals, changes to scope and certificate renewals
- Ensure that certificates accurately reflect our scheme and clients’ requirements
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.About You
To join us as a Scheme Manager, you’ll need:
- At least four years’ experience in the medical device industry or similar working in either a regulatory affairs, product development or quality assurance role.
- Experience of at least one of the following medical device specialities: Orthopaedic implants - specifically joint replacement implants (hip / knee) or spinal devices; Dental implants - titanium screw implants, Guided Tissue Regeneration implants, or dental membranes; General orthopaedic & non-active devices.
- Knowledge of designing and developing medical devices, including the principles of design control, risk management and performance or clinical evaluation
- Track record of managing multiple projects simultaneously
- A BSc, ideally MSc or PhD, in a discipline relevant to medical device manufacture and use (or equivalent)
Other organizations may call this role Regulatory Affairs Manager/Officer, Medical Device Scheme Manager, Certification Scheme Manager, Senior Quality Manager, Senior QA Manager, Certification Project Manager or Senior Audit Manager.
We’re also eager to hear from you if you’ve worked as a Medical Device Specialist, Medical Device Auditor, Medical Device Assessor or Medical Device Development Specialist.
What we offer:
We offer a highly competitive starting salary of Circa £60,000/€70,000 Plus 10-15% bonus. BSI also offers employees a wide range of flexible benefits that you can tailor to suit your life-style.
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.
- Medical Devices
- Quality Assurance
- Regulatory Affairs