Medical Device Regulatory Manager
Our client part of a group of lifescience companies, that is rapidly expanding. Operating from a business model of virtual companies, they secure registrations and deliver to market specialist and niche medicines and medical devices.
This role would be working on the Ophthalmic arm of the business and responsible for all Medical Device regulatory and compliance activities across UK, EU and US markets
Medical Device Regulatory Manager:
* To provide regulatory advice and expertise in relation to identifying and implementing changes in regulatory procedure
* Compile and update technical files for medical device submissions and registrations
* To manage the QMS system and maintain compliance and SOPs
* To assist with the groups transition strategy for MDR and FDA regulatory compliance
* To support the regulatory requirements of new product registration
* Supporting internal and external audits
* Review labelling, support promotional and advertising material
The ideal candidate will have/be:
* At least 5 years experience within Medical Devices regulatory affairs
* Experience working with EU and US markets
* Substantial experience with Technical File creation, classification, registration and Notified Body submissions
* Ophthalmic medical devices exposure preferable
Apply now via this website or contact Rowena in the bath office
Star is a full service resourcing and outsourcing company which resources at all levels for pharmaceutical, medical devices and technology, clinical research and healthcare communications companies in the UK and Ireland on a headcount and outsourced basis. If you haven't heard from us within 7 working days of submitting your application, please assume that you haven't been successful on this occasion. We wish you the best of luck with your job search.
