Regulatory Affairs Lead

GE HealthCare Technologies

Not specified; not specified; competitive salary +...
Hybrid
Pharmacist or master's degree in scientific discipline
Significant experience in regulatory affairs within medical device industry
Advanced knowledge of regional and international regulatory frameworks
GE HealthCare Technologies is seeking a Regulatory Affairs Lead to provide regulatory strategy and direction for product launches and compliance in the healthcare industry. The ideal candidate will have significant experience in regulatory affairs within the medical device sector and possess strong communication, leadership, and project management skills

Job Summary

  • The role provides regulatory strategy and direction for product launches, premarket submissions, and post-market compliance globally.
  • Candidates must possess significant experience in the medical device industry with advanced knowledge of applicable regulatory frameworks.
  • The position requires strong leadership and project management skills to execute programs in a dynamic, matrixed environment.

Matching Summary

Match Score: 85

GE HealthCare Technologies is seeking a Regulatory Affairs Lead to provide regulatory strategy and direction for product launches and compliance in the healthcare industry. The ideal candidate will have significant experience in regulatory affairs within the medical device sector and possess strong communication, leadership, and project management skills.

Salary

Not specified; Not specified; Competitive salary and benefits package

Skills & Requirements

Must-have

  • Pharmacist or Master's degree in scientific discipline
  • Significant experience in Regulatory Affairs within medical device industry
  • Advanced knowledge of regional and international regulatory frameworks

Nice-to-have

  • Strong oral and written communication skills
  • Experience interfacing with regulatory agencies like SAHPRA and NAFDAC
  • Demonstrated ability to influence and build consensus among stakeholders

Key Requirements

  • Pharmacist degree or Master's in scientific discipline
  • Significant medical device regulatory affairs experience
  • Knowledge of IEC, ISO, and regional standards bodies

Work Rights

Not specified

Tailored Resume

Cover Letter