Regulatory Affairs Specialist

1 week ago


Witney, Oxfordshire, United Kingdom Abbott Laboratories Full time
About Abbott Laboratories

Abbott is a global healthcare leader, helping people reach their potential through innovative health solutions. With a diverse network serving customers worldwide, we create new solutions across the spectrum of health, from diagnostics to medical devices and nutrition.

We're committed to advancing healthcare through innovation and our employees play a critical role in this mission. We're seeking a highly skilled Principal Regulatory Affairs Specialist to join our EMEAP regulatory affairs team.

About the Role

Salary Range: $120,000 - $180,000 per year

You will be responsible for leading regulatory activities for cutting-edge medical devices & IVDs in the Europe, Middle East and Africa (EMEA) region. This includes developing business-critical regulatory strategies, coordinating submissions with Notified Bodies and country regulatory contacts, and ensuring timely approvals.

This is an exciting opportunity to work on a wide range of products and projects, collaborating with cross-functional teams to achieve our goals. If you have experience with EU regulations, MDR 2017/745 and IVDR 2017/746, and are passionate about regulatory affairs, we encourage you to apply.

Responsibilities:

  • Develop and lead business-critical regulatory strategies for the EMEA region.
  • Act as regulatory subject matter expert in design control projects and manage roll out programs.
  • Manage creation and development of EU & UK Technical files.
  • Provide coaching and mentoring to junior team members.

Benefits:

  • A competitive salary, bonus, and benefits package.
  • A defined-contribution pension scheme.
  • A share ownership scheme.


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