Regulatory Affairs Specialist
I'm currently working with medical device company based in Clare who are looking for a regulatory affairs specialist to join their team.You will be joining a company that are committed to advancing health care for every person.You will be joining a great team and will be provided with great training and support.
This is a permanent role with great benefits.
What will I be doing as a Regulatory Affairs Specialist?
- Preparation and maintenance of CE technical files in compliance with current IVDD and preparation for compliance to new IVDR.
- Preparation and submission of dossiers and registration documentation for new product registrations and renewal of existing licenses.
- Management of Field Action process for AU products.
- Review and approval of device modification proposals.
- Review and approval of all product labelling.
- Control of distribution of product from regulatory perspective through regulatory stop ship program
- Participation in Internal and External Quality Audit as required.
- Participation in Management Reviews of the Quality & Environment System as required.
- Communication to management on Regulatory affairs issues, which require addressing.
- Support, where required, in Global RA tasks / projects, which may include supporting RA colleagues outside of the company.
What I need to be a Regulatory Affairs Specialist?
- Will be qualified to a minimum of B.Sc. level in a scientific field or other relevant technical field.
- Have a minimum of 1 years' experience in a QA or RA role within a manufacturing facility.
- Excellent written and communication skills are essential.
- Knowledge and understanding of the IVDD Directive and the associated harmonised standards.
- Knowledge and understanding of ISO13485 and the FDA QSRs.
- Experience of product registrations is desirable.
If you think the position in Clare is the step in the right direction for you and have experience in a similar role, don't hesitate in applying. If you think you might be interested in becoming a Regulatory Affairs Specialist and looking for more information, I will contact you upon application and discuss this further with you!
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales