Description
Due to rapid expansion in to new territories and changing regulations my client now has a need for a regulatory affairs manager to keep up to date with all current and future Regulatory Affairs challenges that face the company's products;Key Responsibilities;
- To be aware of both the IVDD and the forthcoming IVD Regulations and their impact on all the group's product and service provisions.
- Where necessary to be prepared to direct FDA studies, submissions and other activities that would be required to enable the group companies to register facilities and pre market notifications.
- Direct Country Specific Registrations, to facilitate the registration of products in countries deemed important for company's products to be marketed in.
- REACH, WEEE, H&S to keep abreast of other relevant regulatory issues that impact on the Diagnostics business.
- IFU/MSDS, to keep the company Instructions for Use and Material Safety Data Sheets up to date with all appropriate regulatory requirements.
Essential Requirements;
- Minimum of 5 years' experience in an in-vitro diagnostic assay Regulatory Affairs environment, or a Medical Device environment.
- Experience of working within an ANVISA and/or an FDA controlled cGMP environment.
- Experience of working under regulatory, quality and design systems requirements as applicable for the in-vitro diagnostics industry or medical device industry.
- Scientific qualification, degree or higher level degree.
- Capable of working independently and creatively to achieve objectives.
The role is paying between £35-40,000 + benefits, and is currently interviewing so if you have the correct experience then please send me your CV and I will be in touch shortly.
To find out more about Real please visit www.realstaffing.com