Regulatory Affairs Specialist

2 weeks ago


Witney, Oxfordshire, United Kingdom Abbott Full time

Abbott is a global healthcare company that develops innovative solutions for the diagnosis, treatment, and prevention of diseases. As a Principal Regulatory Affairs Specialist in the EMEAP regulatory affairs team, you will play a critical role in ensuring the timely introduction of new medical devices and IVDs onto the international market.

Job Overview

You will be responsible for a portfolio of cutting-edge medical devices & IVDs, leading regulatory activities for new product introductions and significant on-market changes for the Europe, Middle East and Africa (EMEA) region. This includes developing, implementing, and maintaining regulatory strategies to ensure compliance with EU regulations such as MDR 2017/745 & IVDR 2017/746.

As a technical expert in ADC devices, you will lead interactions with the Notified Body and country regulatory contacts to resolve issues arising during the regulatory submission review process. You will also provide coaching and mentoring to more junior team members, with the possibility of management responsibilities for a small team.

Salary range: £65,000 - £90,000 per annum depending on location and experience.



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