We have a great opportunity for a Regulatory Engineer to join one of our Medical Device clients based in Lancaster. This is a fantastic opportunity for someone starting their Regulatory Engineering journey, or possibly someone from Quality looking to make the next step into Regs.
Role Overview:
1. Conducting Internal Audits to meet the requirements of ISO 9001, ISO 13485, ISO 14001, ISO 45001 and ISO 50001.
2. Conducting technical file audits and supplier audits.
3. Hosting customer audits and support notified body audits.
4. Promoting ISO 9001:2015 & EN ISO 13485:2016 within a fast-paced manufacturing environment.
5. Assist with matters of regulatory compliance.
6. Project team support and technical file assistance.
7. To oversee the training program activities.
8. Collate complex data and interpret results.
9. To deal with nonconformity, customer complaints and subsequent continuous improvements.
10. To carry out general quality assurance and quality control activities as r...