Director, Quality & Regulatory Business Development-2
GE HealthCare
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Business process management systems
Quality management systems
Process mapping for quality improvement
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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.
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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
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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.
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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