Regulatory Affairs Lead

GE HealthCare UK

Johannesburg, South Africa
On-site
Regulatory requirements for product launch
Premarket submissions and registrations
Postmarket compliance
The job posting is for a Regulatory Affairs Lead at GE HealthCare UK in Johannesburg, South Africa. The role focuses on providing regulatory strategy and direction regarding healthcare industry compliance, requiring extensive experience in regulatory affairs and strong communication skills

Job Summary

  • Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally.
  • The role operates with some autonomy, but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures.
  • Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities.

Matching Summary

Match Score: 85

The job posting is for a Regulatory Affairs Lead at GE HealthCare UK in Johannesburg, South Africa. The role focuses on providing regulatory strategy and direction regarding healthcare industry compliance, requiring extensive experience in regulatory affairs and strong communication skills.

Skills & Requirements

Must-have

  • Regulatory requirements for product launch
  • Premarket submissions and registrations
  • Postmarket compliance
  • Healthcare regulatory bodies
  • Medical device industry experience

Nice-to-have

  • Interfacing with regulatory agencies
  • Postmarket surveillance activities
  • Cross-functional environment experience
  • Influence and build consensus

Key Requirements

  • Pharmacist degree or Master’s degree in scientific discipline
  • Significant experience in Regulatory Affairs
  • Advanced knowledge of applicable regulatory frameworks

Work Rights

Not specified

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