Regulatory Affairs Leader - Ultrasound Probes

Job Description Summary

As a Regulatory Affairs Leader, you will be supporting GE HealthCare's ultrasound probes business. You will be collaborating closely with design and manufacturing teams in our Zipf site, as well as with the global regulatory team.

You will be responsible for providing 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.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Job Description

Roles and Responsibilities

• Provide regulatory leadership and strategic direction for Ultrasound regulatory Probe programs, including global RA support for registration planning, submissions, notified body and quality system audits, and program implementation across a cross-functional team with communication to leadership. Support compliance of premarket submissions/registrations and post market compliance, working closely with healthcare regulatory bodies globally.
• Develop regulatory strategies to help optimize regulatory submission pathways, taking into consideration regulatory requirements (including product testing, clinical data, etc), product claims and country regulatory dependencies to ensure optimized sequencing for submissions.
• Assess changes in existing products and determines the need for new / revised licenses or registrations.
• Review and approve advertising and promotion material to ensure consistency with approved claims and regulatory requirements.
• Contribute to writing and editing technical documents
• Research, analyze, integrate and organize background information from diverse sources for regulatory submissions
• Understand and apply regulatory requirements and their impacts for submissions and pre- and post-market compliance.

Required Qualifications

• This role requires advanced understanding of the Quality & Regulatory Affairs and proven experience working in a regulated field
• Bachelor's degree in biomedical engineering, regulatory affairs or equivalent

Desired Characteristics

• Strong oral and written communication skills.
• Demonstrated ability to analyze and resolve problems.
• Ability to document, plan, market, and execute programs.
• Established project management skills.
• Strong communication skills in English (both written and oral).

GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

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. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

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