Regulatory Compliance Expert
19 hours ago
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.
- 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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