Senior Regulatory Affairs Specialist

Overview

In this role you will drive regulatory strategies and submissions for cutting-edge medical devices and IVDs in the EMEAP region. You will collaborate within a global team to accelerate market access and meet regulatory requirements across MDR/IVDR landscapes. You’ll act as a regulatory expert on design changes and launches, liaising with Notified Bodies and authorities to ensure timely approvals. This position offers the opportunity to shape regulatory pathways within a leading diabetes care portfolio and contribute to Abbott’s mission of better health.

Pay / Benefits

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

Responsibilities

• Formulate, develop and lead regulatory strategies for the EMEAP region.
• Act as regulatory subject matter expert in design control projects, assessing changes and managing roll out programs for existing products and new launches.
• Become a technical expert in ADC devices and support interactions with EU Notified Body/UK Approved Body, as well as competent authorities, as required.
• Manage the creation and development of EU & UK Technical files in accordance with MDR 2017/745, IVDR 2017/746 and other application regulations.
• Provide coaching and mentoring to more junior team members
• Identify and implement process improvements and efficiencies per the global regulatory affairs strategy.

Key requirements

• Knowledge of MDR 2017/745 Regulations and ISO13485 is essential
• knowledge of IVDR 2017/746 is preferred
• Experience within a medical device or healthcare manufacturing industry in a regulatory or quality role
• Experience of Technical File creation and maintenance, as well as post market changes
• Experience of working with Notified Bodies and/ or other regulatory bodies
• Excellent written and oral communication skills

• excellent written and oral communication
• coaching and mentoring
• cross-functional collaboration
• MDR 2017/745
• IVDR 2017/746
• EU & UK Technical files

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