SRG have an exciting opportunity for a highly proactive and motived individual to join an established diagnostics company as a Regulatory Affairs Officer based in Newcastle.
As a Regulatory Affairs Officer, you will be responsible for ensuring all products adhere to all regulations in all registered territories. You will also be compiling regulatory submissions, maintaining compliant medical device files, and supporting the complaint development and support of future products.
- Identifying potential improvements and efficiencies and helping to develop, revise and implement company procedures and policies
- Working with the Quality and Regulatory team to ensure products and design and development of future products are compliant with the requirements of relevant global regulatory requirements including IVDR, REACH (UK & EU), CLP (UK & EU) with experience of ISO 13485 and ISO 14971
- Assist with compilation and maintenance of compliant technical files, summaries, and indices
- Prepare and maintain product requirement trace matrices using Aligned Elements software
- Ensure technical and scientific data is collected and reported in line with relevant regulatory requirements.
- Support the QARA team by attending and providing feedback on training and mentoring activities
As the ideal candidate, you will have a minimum of 2 years' experience in medical devices under an ISO 13485 compliant Quality Management System, along with experience of IVD medical device regulations. You will be highly motivated, adaptable and enthusiastic.
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