Regulatory Affairs Specialist
4 days ago
An exciting opportunity has arisen for a skilled Regulatory Affairs Specialist to join the patient safety team at NHS, as part of the Transformation Directorate's Digital Clinical Informatics (DCI) team.
The role will support the quality and regulatory team in implementing and maintaining NHS-England's quality management system in compliance with ISO 13485 and in regulatory activities for NHS England's software medical device products (SaMDs). This includes crucial national impact products such as 111 online and Pathways (underpinning 999 service).
Main Responsibilities- Support the quality and regulatory team in implementing and maintaining NHS-England's quality management system
- Contribute to regulatory activities for NHS England's software medical device products (SaMDs)
- Collaborate with cross-functional teams to ensure compliance with regulatory requirements
- Bachelor degree with 2 years experience in QA/RA in the medical device industry
- Good understanding of ISO 13485 and UK MDR 2002
- Cross-functional, risk-based and innovative thinking skills
- Accurate and punctual attitude
- Good presentation and communication skills
- Good knowledge of English (written and spoken)
- Team-player
- Experience in Quality Management Systems for Medical Devices
- Audits
- Strategic thinking
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
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