Cure Talent are delighted to be partnered with a well-established, British Medical Device Manufacturer who, due to continued growth and investment, have an exciting opportunity for a Regulatory & Quality Assistant to join their team.
This role is predominantly Regulatory Affairs focused, supporting the creation and maintenance of Technical Files and regulatory submissions in line with ISO 13485, MDR and UK MDR requirements. The position will also involve elements of Quality Assurance, including internal auditing and supporting the ongoing compliance of the Quality Management System.
The ideal candidate will have a proven background within Medical Device Regulatory Affairs and possess a strong understanding of ISO 13485 and medical device regulations. You will have experience in the creation and/or updating of Technical Files under MDR, assisting with regulatory submissions and internal auditing.
Key Responsibilities:
- Assist with the preparation of regulatory submissions and Technical Files to EU MDR 2017/745 and UK MDR 2002
- Conduct internal audits and follow up on corrective actions
- Maintain documentation including procedures, protocols, validation reports, audit records, and CAPAs
- Support the maintenance of the company’s QMS in accordance with ISO 13485:2016
- Monitor changes in regulations and support implementation of updates to internal processes
- Collaborate with cross-functional teams including Engineering, Design, Sales, and Customer Service to ensure compliance is embedded throughout the organisation
- Provide support during notified body, supplier and customer audits
The ideal candidate will have:
- Proven experience in a Regulatory Affairs focused role within medical devices
- Experience in the compilation and updating of Technical Files under MDR
- Proven knowledge and experience of ISO 13485, EU MDR, and UK MDR
- Experience with Class 2a devices as a minimum
- ISO 13485 Internal or Lead auditor qualification is highly advantageous
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