Project Manager

Description:

Looking to make your mark within the regulatory space at an exciting organisation looking at IVD's?

I-Pharm has partnered with a rapidly expanding global cooperation that specialises in advanced medical devices. This market leader is in a phase of exponential growth and as a result they are looking for a Senior RA Specialist - Project Manager on a permanent basis working remotely.
 

This market leader operates across EMEA and North America.

The role offers remote working and will involve but not be limited to:
 

• Prepares responses to regulatory agency questions and other correspondence
• Be apart of the new product development regulatory affairs team for in vitro diagnostics product range.
• Represent company for 3rd party submissions for FDA, Notified Bodies, and global regulatory authorities
• Support key development projects to meet strategic business objectives
• Manage global submissions including EU, FDA
• Assist in all regulatory affairs activities contributing to overall company objectives
• Support compliance activities for QMS to meet regulatory requirements including MDSAP

As a Senior RA Specialist - Project Manager, you will need:
 

• Minimum of 2 years of experience working in IVD
• 510k - Presubmissions experience required
• Scientific background