Senior Manager Regulatory Affairs

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.

Location: Edinburgh, GB

Posted Date: 5/8/2025