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:
* Guide the organisation on RA and Quality strategy and activities
* Ensure that all technical documentation is kept up to date
* Manage company wide compliance with ISO13485, IVDD, IVDR, FDA and Canadian Medical Device Regulations, and other global regulations
* Interpret complex legislation and deliver advice to various team members
* Assist with the implementation of the Company's Quality Policy
* Lead projects including product license applications
* Compile and submit initial registration/approval submissions in international markets
Key Requirements
A scientific degree and at least several years' experience are needed, covering areas including but not limited to:
* US regulatory applications and EU CE marking (IVDD/IVDR)
* Post-market surveillance
* Medical device manufacturing
* Managerial and leadership experience
* An independent and responsible personality; a strong sense of self
Why Apply?
* Join an established yet growing organisation at the forefront of complex in-vitro diagnostics!
* Various opportunities for growth, progression and future secondments abroad
* A collaborative, supportive and team orientated environment - regular team incentives and activities for bonding foster an amazing internal culture
* State of the art manufacturing facilities and offices in Scotland (and the UK's) best city🤩
Apply now by hitting 'Easy Apply' or email dion@entrustrs.com for a confidential chat.