£ 70000.00 per annum
Job Type:
Job Owner:
Kris Holmes
An exciting start-up IVD Medical Device company based in Cambridgeshire have an exceptional opportunity for a QARA Manager to join the team due to their continued growth.
As the new QARA Manager, you will be responsible for the development, improvement and maintenance of the QMS, regulatory requirements for the business and the full product lifecycle of both existing and new devices & products.
To be successful in this role you will have a strong background and experience in a QA and/or RA position within the Medical Device and/or IVD sector. A strong knowledge and experience of maintenance and development of ISO 13485, ISO 14971 and with the MDD to MDR transition. A BSc/BEng in a related field is highly advantageous.
Skills/Experience/Knowledge Required:
Strong Experience in ISO 13485 and medical device regulations (MDD and MDR)
Experience and knowledge of ISO 13485 associated documentation
Risk management ISO 14971 experience
Bachelor's degree in a related field (advantageous)
If you have the experience, knowledge and skills to be successful in this role, please apply now to get in touch.