RA / QA Specialist
Regulatory Affairs / Quality Assurance Specialist
Industry: Medical Devices
Full time / Office based
Competitive salary and benefits
This global Medical Technology organisation specialises in providing market leading Orthopaedic products to the Healthcare Industry. Due to continuous growth they now have an exciting opportunity for a Regulatory Affairs & Quality Assurance specialist to join their highly professional team in Warwickshire.
Representing the Regulatory Affairs & Quality Assurance function for all Field Safety Corrective Actions (FSCA), including reporting related activities to the competent authorities
Assisting the Group Manager with other RA duties as required
Dealing with product registrations
Managing certificates with the MHRA
Acting as a single point of contact with the UK & Ireland Competent Authorities for FSCA and related matters
Collating and reporting evidence of FSCA closure for each affected country within EU & Canada region
Developing and assisting in product registrations & re-registrations, including the supply of necessary documents (e.g. certificates of the marketability, authentications, etc) for Europe & Canada and to existing approved countries for their products. Working with the MHRA in managing and obtaining Free Sales Certificates, legal for Notary signatures and Embassies for Legalisation of documents for the customers.
Assisting in the development, reviewing and implementing regional policies and procedures based on corporate and regional requirements (e.g. current MDD and new MDR coming into force)
Successful candidates will have the followings skills & experience:
Experience of working within Regulatory Affairs within the Medical Devices sector Essential
Previous experience of working within the Quality Assurance department, working to ISO 13485 standards Essential
Global experience of dealing with the MHRA is also required for this role Essential
You will also have experience of dealing with recalls Essential
Please note in order for your application to be successful you must hold a valid right to work document for the UK as no sponsorship is offered.
To apply for this role please send your CV through to Kully Sahota, Senior Consultant, Kully.email@example.com or call 0207 822 1710 for more information