Leeds, West Yorkshire
over 1 year ago
Regulatory and Quality Officer
A new opportunity for a Regulatory and Quality Officer has recently become available to join an international medical device company that are leading the way in biological technology.
As a Regulatory and Quality Officer you will support the RA/QA Manager in maintaining a QMS that meets the applicable regulatory and company requirements (such as ISO 13485, EU Medical Device Directive/Regulation (MDD/MDR), EN/IEC 62304, ISO 14971, etc.)
* You will support in product submissions, licence renewals, periodic updates and registrations to regulatory agencies (FDA and EU regulatory entities)
* Assist in the creation and review of design dossiers technical files, and Product Approval Certificates.
* Update and maintain all Design History Files and associated documents.
* Coordination of post-market activities e.g. surveillance, customer feedback, failure analysis.
* Update and review all IFU, Packaging, Labelling and Art Work approval.
We are interested in speaking to individuals who have experience within the medical device, pharmaceutical or cosmetics industry. Ideally educated to honours degree level in a scientific field or equivalent experience. You will be efficient, well organised and have a systematic and methodical approach to work.
Key Words: Regulatory Affairs, QA, Quality Assurance, Medical Device, Technical Files, Design History Files, ISO 13485, Post Market Surveillance, Art Work approval, QMS.
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