I am currently working with a global and industry leading buisness in the Biotechnology space looking to recruit a Regulatory Affairs Manager into their business. The role will be both a team lead and responsible for all regulatory affairs across the relevant markets.
The role will involve:
- Lead, manage and organise a team of regulatory affairs professionals responsible for the regulatory aspects of their IVD products- You will be responsible for managing global markets submissions including EU, FDA- You will hands on involvement and responsibility for 3rd party submissions for FDA, Notified Bodies and global regulatory authorities- Support Internal audits
My client are looking for candidates with a background in management or supervision within a QA/RA roles prefferably in IVD/Medical Devices but pharma backgrounds will be considered.
In addition, the right candidate will have a substantial amount of post graduate experience dealing with FDA submissions for PMA, 510k, presubmissions etc
If you or anybody in your network would be interested in this role then please do get in contact on 0121 726 9711 or firstname.lastname@example.org
your application has been submitted