Job Description
Regulatory Affairs Division Leader - Diagnostics
Edinburgh area
Hybrid
Join a leading medical equipment manufacturer at the forefront of pioneering In-vitro diagnostics. With manufacturing sites across Switzerland and Scotland, their Regulatory function spans globally.
After receiving significant, sizeable investment to back a brand new, innovative product portfolio, they are scaling up manufacturing operations and breaking into the US market with FDA product approval. This is a significant period for the business as they assemble a US based commercial team to begin operations overseas.
As a Regulatory Affairs Division Leader, you will lead an existing team to success across global markets. This requires delivering organisational wide strategy and requires a high degree of responsibility and due diligence!
Some Core Responsibilities
Carry our Regulatory responsibilities including but not limited to:
1. Guide the organisation on RA and Quality strategy and activities
2. Ensure that all technical documentation is kept up to date
3. Manage company wide compliance with ISO13485, IVDD, IVDR, FDA and Canadian Medical Device Regulations, and other global regulations
4. Interpret complex legislation and deliver advice to ...