Industry: Medical Devices
Salary: £25,000 - £30,000
This is a great opportunity for a Regulatory Affairs Officer to join an exciting start-up company based in Wokingham. The company specialise in both the design and manufacture of IVD devices.
The successful Regulatory Affairs Officer will be expected compile and maintain EU technical files as per IVDD directive whilst also assisting with the transition from IVDD to IVDR.
Regulatory Affairs Officer Requirements:
* Experience in a regulatory affairs or quality assurance role at a medical device company
* Experience working to IVDD would be beneficial
* Able to assist in the performance of both internal & external audits
* Be enthusiastic with a passion for the job & able to fit in with this dynamic and driven team
Regulatory Affairs Officer Responsibilities:
* To assist with the transition from IVDD to IVDR
* To compile and maintain EU technical files
* Assist with the correspondence with regulatory agencies and notified bodies
* Asist in both external & internal audits
If you are interested in this regulatory affairs officer opportunity, please click apply now and we will be in touch with you soon.