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Regulatory Affairs Officer

2 weeks ago

Newcastle Upon Tyne, United Kingdom Real Staffing Full time

**Regulatory Affairs Officer**

Our client a medical device company specialise in molecular diagnostic medical devices such as COVID-19 PCR tests. They have investment to expand and work with clients all over the world to assist them to bring their innovative medical device testing systemto market.

**Responsibilities**
- The Regulatory Affairs Officer you will implement process improvements and efficiencies and report to the Regulatory Affairs Manger
- Assist with compilation and maintenance of compliant technical files, summaries, and indices
- Ensure research and development is carried out in line with regulatory requirements
- Support post-market data gathering and reporting in line with regulatory requirements and company Post Market Surveillance and Vigilance procedures.
- Manage projects and communicate and collaborate with QRA team
- Ensure technical and scientific data is collected and reported in line with relevant regulatory requirements
- Contribute to assessment for impact on the company's QMS
- Design review and control of change processes
- Regulatory Affairs Officer will support administration of a company-wide risk-based comprehensive training system
- Prepare dossiers for submission to product licensing and gather post-market data and reporting
- Prepare and maintain product requirement trace matrices using Aligned Elements software
- The Regulatory Affairs Officer will support the compliance training for employees and take charge of third party audits
- Compliant software development and compliance review

**Desirable skills**
- Worked within the Medical Device sector
- Knowledge of IVDR or MDR and FDA
- ISO 13485 Compliant under QMS

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England andWales