Senior Regulatory Affairs Manager

4 days ago


Witney, Oxfordshire, United Kingdom Abbott Full time
About Abbott

At Abbott, we're committed to advancing the future of healthcare. With a diverse global network serving customers in over 160 countries, we create innovative solutions across the spectrum of health, from diagnostics to medical devices, nutrition, and more.

Senior Regulatory Manager, Clinical Affairs Role

We're seeking a highly skilled Senior Regulatory Manager to join our Clinical Affairs team. As a key member of our regulatory affairs team, you'll play a critical role in ensuring our products meet regulatory requirements and comply with industry standards.

Main Responsibilities
  • Develop and implement global regulatory strategies to ensure compliance with changing regulations.
  • Provide strategic guidance on product development and planning throughout the product lifecycle.
  • Lead crisis management program development and implementation.
  • Recruit, develop, and manage regulatory professionals.
  • Approve regulatory filing strategies and review labelling for compliance.
  • Represent regulatory affairs in product recall and recall communication processes.
  • Negotiate with regulatory agencies and participate in political lobbying.
  • Develop and communicate a vision for the organizational unit assigned.
  • Provide technical leadership to business units.
Requirements
  • Bachelor's Degree in Science, Math, or a medical field (Master's Degree in a technical area or MBA preferred).
  • Strong knowledge of regulatory affairs and industry standards.
  • Excellent communication and leadership skills.
What We Offer

At Abbott, we offer a competitive salary, excellent benefits, and a range of optional initiatives to help our employees live life to the fullest. Join our team and contribute to shaping the future of healthcare.



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