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Regulatory Affairs Specialist

1 month ago

West Yorkshire, United Kingdom NHS Full time
Chemical Regulatory Affairs Specialist

An exciting opportunity has arisen for a skilled regulatory specialist to join the patient safety team as part of the Transformation Directorate's Digital Clinical Informatics (DCI) team.

The role supports 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). Crucial national impact products such as 111 online and Pathways (underpinning 999 service) form part of this portfolio.

We apply robust quality and regulatory governance and oversight to ensure all products that qualify as Software medical devices are developed, deployed and maintained as per the relevant regulatory requirements.

Main Responsibilities
  • Support the quality and regulatory team in implementing and maintaining NHS-England's quality management system
  • Assist in regulatory activities for NHS England's software medical device products (SaMDs)
  • Apply robust quality and regulatory governance and oversight to ensure compliance with ISO 13485 and relevant regulatory requirements
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
  • Ideally hands on experience in QA/RA for software medical device
  • Ideally experience of performing audits
Experience and Knowledge
  • Experience in Quality Management Systems for Medical Devices
  • Audits
Skills and Attributes
  • Strategic thinking
Disclosure and Barring Service Check

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.