Description
The general responsibilities of the role are as follows;- Taking responsibility of the global submissions & registrations of new and existing products in new and current territories.
- Provision of regulatory guidance throughout product development and change, including regulatory advice on exporting devices outside of the EU.
- Interact with, and act as a representative with notified bodies in foreign and home territories.
- Act as Management Representative for all 3rd party Quality System Audits/Inspections (BSi, FDA, customer audits, etc) at the Bourton facility, including both manufacturing and distribution operations.
- Group wide implementation of the Quality/Business, including System Management of the internal Quality System audit and CAPA agendas for relevant business units
- Regular feedback to line manager, including preparation and submission of monthly reports and performance dashboards
- Presence on and attendance at monthly Operational Team Meetings and presentation of relevant issues and project progress reports to the team
- Travel toFrance/Germanyas required in connection with fulfilling the role.
Essential Requirements for the role are as follows;
- In-depth understanding and experience of ISO 13485 and/or ISO 9001, ISO 14971, and the MDD 93/42/EEC
- Experience in the implementation of Quality Systems in compliance to FDA 21.CFR.820
- Experience in completing global submissions for Medical Devices in the EU,USA,Braziland Far East. (Not all required)
- Accustomed to working with Notified Bodies and external consultancies, successful completion of surveillance and technical audits as Management Representative
- Line management experience, including individual staff motivation, development plans, performance management
- Experience of FDA Establishment inspections, including resolution of issues and successful completion / closure
- Experience in the preparation of 510(k) submissions to FDA
- Management of staff in remote facility
- Orthopaedic industry knowledge and experience
My client is paying a salary of £50-55k Plus full benefits package, If you believe you have the correct experience then please forward me your CV and I will be in touch shortly
To find out more about Real, please visit us on www.realstaffing.co.uk