Reference Number: JO-2104-466241
Rate: £53,000 – 55,000
Job Type: Permanent
Regulatory Affairs / Quality Assurance Manager
Location: Sevenoaks, Kent
Salary: Up to £55,000 per annum + benefits
CPL Life Sciences are collaborating with a growing medical device business in Kent. The company was established almost 40 years ago and has a robust portfolio of developing and marketed dental products. In this role, you will be responsible for all Regulatory Affairs and Quality Management activities, from product registration to quality audits, and be the main point of contact for notified bodies.
· Oversee and continually review the quality management system
· Ensure that a quality system is established, implemented and maintained (in accordance with the latest guidelines
· Provide sound advice to management on regulatory requirements for the development of new products.
· Manage, maintain, and implement CAPAs
· Review final manufacturing and inspection records and assign status including a release for despatch.
· 5+ years’ experience working within a RA/QA position
· In-depth understanding of technical transfers for class I & II medical devices in Europe
· Good understanding of the MDD and MDR
· Experience working with competent authorities and notified bodies.
If you are interested in this role or would like more details please email your CV Charlie.firstname.lastname@example.org or call Charlie on 01189 522797
Remember if this role is not suitable for you please feel free to forward this to anyone you feel would be suitable. If we successfully find a role for your recommendation we will give you £250 in vouchers of your choice.