Senior Regulatory Affairs Specialist
Abbott · Witney, UK
RegulatoryFull-timeCompany career page
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Role summary
Abbott seeks a Senior Specialist in Regulatory Affairs to lead regulatory strategies and submissions for medical devices and in vitro diagnostics across Europe, Middle East, Africa, and Pakistan. The role involves coordinating technical file development, engaging with regulatory bodies, and mentoring junior staff within a growing EMEAP regulatory team.
What they're looking for
- Bachelor's degree in scientific discipline such as chemistry, life sciences, or biology
- Knowledge of MDR 2017/745 and ISO 13485 regulations; IVDR 2017/746 preferred
- Experience in medical device or healthcare manufacturing regulatory or quality roles
- Demonstrated expertise in technical file creation and post-market change management
- Experience working with Notified Bodies and regulatory authorities
- Strong written and verbal communication skills for regulatory documentation and stakeholder engagement
What you'll be doing
- Formulate and lead regulatory strategies for the EMEAP region's product portfolio
- Oversee technical file preparation and coordinate submissions with Notified Bodies and competent authorities
- Serve as regulatory expert on design control projects and manage product changes and launches
- Coach and mentor junior regulatory affairs team members
- Identify and implement process improvements aligned with global regulatory strategy
Privacy & handoff
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