Global Regulatory Strategy Leader

GE HealthCare; Madison (WI); On-site; USD 120,000 - 180,000; Full time

Job summary

GE HealthCare is seeking a Regulatory Affairs Leader to provide strategic regulatory leadership for major projects and submissions. You will work with cross-functional teams and global regulatory bodies to ensure best practices and compliance across premarket submissions, post-market activities, and regulatory intelligence.

GE HealthCare is a leading global medical technology and digital solutions innovator.

Qualifications

• This role requires advanced experience in the Quality & Regulatory Affairs.
• Knowledge level is comparable to a Bachelor's degree from an accredited university or college.
• Minimum of 3 years experience working in a regulated field.
• Strong communication skills in English (both written and oral).

Responsibilities

• Provides regulatory leadership and strategic direction for RA programs and global submissions.
• Supports compliance of premarket submissions and post-market activities with global bodies.
• Develops regulatory strategies to optimize submission pathways across countries.
• Explains information clearly and builds team consensus on regulatory topics.
• Reviews advertising and promotion material for regulatory alignment.
• Contributes to writing and editing technical regulatory documents.

Skills

Regulatory leadership

Project management

English communication

Analytical thinking

Education

Bachelor's degree in a relevant field

Job description

GE HealthCare is seeking a Regulatory Affairs Leader to provide strategic regulatory leadership for major projects and submissions. You will work with cross-functional teams and global regulatory bodies to ensure best practices and compliance across premarket submissions, post-market activities, and regulatory intelligence.

GE HealthCare is a leading global medical technology and digital solutions innovator.