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Job Location | Newcastle Upon Tyne |
Education | Not Mentioned |
Salary | 28,000 - 35,000 per annum |
Industry | Not Mentioned |
Functional Area | Not Mentioned |
Job Type | Permanent , full-time |
We are currently recruiting for a Regulatory Affairs Specialist to join our client in the Medical Device sector on a full-time permanent basis in Newcastle. This role can pay a top role salary of £35,000 DOE.The RA Officer is responsible for helping to ensure the companys products comply with regulations in all registered territories. The RA Officer will help to compile regulatory submissions relating to products, maintain compliant medical device files andsupport the compliant development of future products. The RA Officer will also be involved in the improvement and support of the companys Quality Management System alongside the QRA team by identifying potential improvements and efficiencies and helping todevelop, revise and implement company procedures and policies.The RA Officer will work with the QRA team to ensure products and design and development of future products are compliant with the requirements of relevant global regulatory requirements including, but not limited to IVDR, REACH (UK & EU), CLP (UK & EU)with experience of ISO 13485 and ISO 14971 and ideally familiarity with IEC 62304.Key Roles & Responsibilities: