Do you want to play a vital role in the execution of MDSAP globally for BSI?
Do you have a great understanding of quality management systems (ISO 13485) and medical device regulation including the applicable country regulations and standards?
If so, our new exciting role in our Global Medical Device team as a Global MDSAP Certification Lead could the the opportunity for you... This role is homebased and you can be located in either the UK, France, Germany, the Netherlands, Spain, or Italy.
In this role you'll be involved with the global Medical Devices MDSAP initiative for BSI, supporting co-ordination and embedding of requirements in BSI systems and processes.
This will include leading on the alignment within BSI of relevant policies, procedures and documentation to meet its MDSAP regulatory obligations and work with regional and global Medical Device management in the execution of relevant processes to meet these obligations.
You'll provide Medical Device MDSAP mentoring and training to relevant BSI colleagues and support BSI’s implementation of MDSAP and transition of CMDCAS for existing clients in the MDSAP scheme consistent with requirements of other QMS schemes, e.g., UKAS, RvA and SCC.
You'll be the main point of contact for the delivery of Global BSI MDSAP initiative, MDSAP service to BSI Healthcare clients, assist QMS assessors, Technical Specialists, Scheme Managers, Sales, Marketing and other BSI Colleagues on MDSAP requirements.
It'll will alos be important for you to monitor MDSAP Assessor capacity and competency to deliver MDSAP assessments as well as provide MDSAP assessment mentoring, to assist with support to QMS Assessors, Global Heads, Product Specialists and Scheme Managers on MDSAP audits and certifications in area of expertise that may have a regulatory challenge.
In additon you'll;
The position also gives the opportunity to conduct around 25% travel annually to BSI and third party locations across EMEA for business and representative meetings.
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 device; 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 is exciting opportunities for further growth of the Medical Devices team.
A good understanding of quality management systems (ISO 13485) and medical device regulation including the applicable country regulations and standards is vital fo success in this role as well as thorough knowledge of Medical Device QMS standards and regulations.
You'll have a good understanding of product and QMS certification concepts and principles, quality systems, philosophies and principles and internal auditing principles and practices including knowledge of BSI, its role and its approach to certification
In additon knowledge of the application of accreditation/designation, notified body, product and quality systems standards and requirements are important along with a degree in engineering, science or related discipline.
What we offer:
We offer a highly competitive starting salary and 15% bonus. We are offering 27 days annual leave with the opportunity to increase this to 30 days, company-paid private medical insurance, an excellent company-contributed pension scheme, and 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.
Take a look at our excellent UK Benefits