Regulatory Affairs Officer Newcastle-Upon-Tyne Permanent role Salary circa £30K (DOE)A leading UK Medical Device manufacturer, based in Newcastle-Upon-Tyne, are currently looking for a Regulatory Affairs...
RA Registration & Vigilance Officer
Newcastle upon Tyne
Salary £26-£37K (DOE)
A UK based award winning designer and manufacturer of single use medical devices. They have over 50 years' manufacturing experience and currently export to over 80 countries worldwide. With an average length of service of 11 years' and an excellent flexible working policy, they currently employ over 270 people and are going through a period of accelerated growth. They are currently looking to recruit an RA Registration & Vigilance Officer to join their team in Newcastle upon Tyne.
The successful RA Registration & Vigilance Officer will:
- Cover and maintain the RA/QA system in accordance with the latest relevant standards for the product ranges produced.
- Assist in regulation/registration of devices with worldwide regulatory bodies.
- Control the company vigilance system, ensuring all information is available and up to date.
- Advise on country requirements with regards to vigilance handling.
- Ensure all licencing information is logged onto Q Pulse system.
To be considered for the RA Registration & Vigilance Officer role you will have:
- Working knowledge of ISO 13485 & 93/42/EEC
- An understanding of Regulatory authority's product and company registration routes/requirements.
- Knowledge of drafting a Market Authorisation Application.
If you have experience in Regulatory Affairs and are looking for the next step in your career please apply online. Any queries can be directed to Kristi on 0191 284 6768.