Description
This specialist will be responsible for implementing an efficient programme to ensure that all Europe,Middle Eastand African Registrations (EMEA) including Technical files are completed in the agreed schedule. They will work closely with the current Regulatory manager to develop a strategy to introduce new products to the international markets.This Will Involve;
- Technical file documentation.
- International Product Submissions.
- Working with theUSAand communicating regulatory requirements.
- Implement and Develop Technical files for both IVD and Medical device Directives.
- Maintain the Quality Management System to a high standard.
Minimum Requirements;
- Experienced in regulatory submissions for in vitro diagnostic devices and/or medical devices.
- Experience of working within the requirements of ISO 13485, the Medical Devices Directive (93/42/EEC)and/or the IVD Directive (98/79/EC).
- Educated to degree level or equivalent preferably in a Scientific or Engineering discipline.
This role is perfect for someone who is 2-5 years in to a medical devices career that has experience within IVDs.
We offer a £200 referral fee for any one who is referred to us that is successful, so if you know someone who is suited then please forward this on to them.
If you believe that you have the required experience then please get in touch with Joseph on .
To find out more about Real please visit www.realstaffing.com