£30000 - £35000 per annum + Corporate Package
7 days ago
Quality / Regulatory and Compliance Specialist - Remote Working
A world leader within Medical Devices are offering the opportunity to join their growing Quality team with a focus on Quality Auditing, Regulatory and Compliance. This opportunity will provide the successful candidate with the chance to progress and build upon their skills with a well-known and reputable organisation.
As a Quality specialist you will be responsible for supportingand maintaining the global Quality Management System along with identifying opportunities for improvement. You wil be the interface between Customers, Authorities and certification bodies (MHRA/HPRA) and Manufacturers in order to satisfy customers and support business activities.
Ensure the organisation is operating in a fully compliant way according to the regulations/ standards.
+ Supporting and maintaining the QMS based on ISO9001 and ISO13485
+ Regulatory Affairs
+ Post marketing surveillance - product compliants products
Experience and qualifications;
+ Quality experience within the medical field
+ Experience in QMS in the medical device industry is desirable
+ Good knowledge of Excel, Word & Powerpoint
+ Knowledge of ISO 13485 / ISO 9001 / desirable.
+ Knowledge in Medical device regulation (MDR, UKMDR), MDD (DIR 93/42/CEE) and local medical device regulations desirable
The role is remote working with some travel to both client sites and head office inc Mansfield & Sunderland, so a driving license is required.