Regulatory Compliance Expert

19 hours ago


St Albans, Hertfordshire, United Kingdom X4 Life Sciences Full time
Job Title: Regulatory Compliance Expert

We offer a salary range of £40,000 to £45,000 for this role.

X4 Life Sciences is a leading medical device company seeking a regulatory compliance expert to join its quality team. In this role, you will be responsible for ensuring compliance with regulatory requirements.

About the Role:
  • Maintain and improve the QMS, covering aspects such as CAPA, RCA, change control, document control, risk assessments, and internal, supplier, and customer/notified body audits.
  • Lead validation processes, including IQ/OQ/PQ, in NPI project teams.
  • Handle quality-related correspondence and serve as the primary point of contact for a portfolio of customers.
  • Analyze data to produce reports that inform improvement initiatives.
Required Qualifications and Experience:
  • Degree qualification or relevant experience in a regulatory compliance role.
  • Strong understanding of ISO 9001 or ISO 13485:2016 standards.
  • Experience in auditing and quality assurance roles.
  • Able to work effectively both independently and as part of a team.

The ideal candidate will have excellent analytical and problem-solving skills, with a strong understanding of regulatory requirements.



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