Director, Quality & Regulatory Business Development-2

GE HealthCare

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Business process management systems
Quality management systems
Process mapping for quality improvement
** GE HealthCare is seeking a Director of Quality & Regulatory Business Development to enhance business development capabilities within the medical device industry. The ideal candidate will have extensive experience in quality management systems and regulatory compliance, particularly with FDA and ISO standards. **

Job Summary

  • Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements.
  • GE Healthcare is a leading global medical technology and digital solutions innovator.
  • GE Healthcare offers a great work environment, professional development, challenging careers, and competitive compensation.

Matching Summary

Match Score: 75

** GE HealthCare is seeking a Director of Quality & Regulatory Business Development to enhance business development capabilities within the medical device industry. The ideal candidate will have extensive experience in quality management systems and regulatory compliance, particularly with FDA and ISO standards. **

Skills & Requirements

Must-have

  • Business Process Management Systems
  • Quality Management Systems
  • process mapping for quality improvement
  • standardization of processes, tools, and performance management
  • industry trends analysis

Nice-to-have

  • influence strategy development
  • lead functional teams or projects
  • communicate difficult concepts
  • assess quality of information
  • develop novel solutions
  • strong team connections

Key Requirements

  • Master's degree with 5 years of experience in medical device industry
  • Bachelor's degree with 10 years of experience in medical device industry
  • High School Diploma with 15 years of progressive responsibility in medical device industry
  • Experience with medical device QMS and regulatory requirements
  • FDA 21 CFR Part 820 and ISO 13485
  • Minimum of 5 years of experience directly driving global programs to resolve quality compliance issues

Work Rights

Legally authorized to work in the United States

Tailored Resume

Cover Letter