Senior Regulatory Affairs Specialist

Overview

In this role you drive regulatory strategy for cutting-edge medical devices and IVDs in the EMEAP region, coordinating global submissions and interactions with notified bodies to enable timely market approvals. You will be a regulatory expert on design changes and new launches, coaching junior colleagues and driving process improvements. The position sits within Abbott’s global regulatory team, contributing to a strong product pipeline and regulatory readiness across markets. You will work at the intersection of science, quality and regulatory operations to help bring innovative diagnostics and devices to patients.

Pay / Benefits

• defined-contribution pension scheme
• share ownership scheme
• private healthcare
• life assurance
• flexible benefits scheme

Responsibilities

• Formulate and lead regulatory strategies for the EMEAP region
• Act as regulatory SME in design control projects and manage rollout programs for existing products and new launches
• Develop expertise in ADC devices and support interactions with EU Notified Body/UK Approved Body and competent authorities
• Create and maintain EU & UK Technical files in accordance with MDR 2017/745, IVDR 2017/746 and related regulations
• Provide coaching and mentoring to junior team members
• Identify and implement process improvements aligned with the global regulatory affairs strategy

Key requirements

• Knowledge of MDR 2017/745 and ISO13485 is essential; IVDR 2017/746 knowledge preferred
• Experience in regulatory or quality roles within medical devices or healthcare manufacturing
• Experience with Technical File creation and post-market changes
• Experience working with Notified Bodies or regulatory authorities
• Excellent written and oral communication skills for reports and cross-department collaboration

• strong communication
• coaching/mentoring
• cross-functional collaboration
• MDR 2017/745
• IVDR 2017/746
• ISO 13485

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