Regulatory Affairs Lead Specialist (fixed Term Contract - Maternity Cover) - Spécialiste Principal(e) En Affaires Réglementaires (cdd – Remplacement Congé Maternité)

GE HealthCare UK

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Advanced experience in regulatory affairs
Bachelor's degree or equivalent experience
Proficiency in english written and spoken
** GE HealthCare is seeking a Lead Specialist in Regulatory Affairs for a fixed-term contract covering maternity leave. The role involves leading global regulatory projects and collaborating with cross-functional teams to bring innovative mammography imaging products to market. **

Job Summary

  • This global leadership position offers the opportunity to drive regulatory strategies and lead cross-functional teams to bring innovative Mammography imaging products to market.
  • The role involves preparing and submitting regulatory documentation to authorities across major international markets including the US, Europe, China, and Asia.
  • Candidates will provide regulatory guidance throughout the product lifecycle to ensure compliance with international standards and support inspections.

Matching Summary

Match Score: 75

** GE HealthCare is seeking a Lead Specialist in Regulatory Affairs for a fixed-term contract covering maternity leave. The role involves leading global regulatory projects and collaborating with cross-functional teams to bring innovative mammography imaging products to market. **

Skills & Requirements

Must-have

  • Advanced experience in Regulatory Affairs
  • Bachelor's degree or equivalent experience
  • Proficiency in English written and spoken
  • Strong analytical and problem-solving skills
  • Experience with medical device product development

Nice-to-have

  • Experience interacting with FDA and NMPA
  • Knowledge of Quality Management Systems QMS
  • Ability to work autonomously in fast-paced environment
  • Experience in multicultural cross-functional teams
  • Adaptability to drive positive transformation

Key Requirements

  • Advanced experience in Regulatory Affairs within medical device industry
  • Bachelor's degree from an accredited university
  • Excellent oral and written communication abilities in English

Work Rights

Not specified

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