Lead Specialist, Regulatory Affairs - WHXR

Key Responsibilities

• Lead global regulatory projects to secure market authorization and promotional approval for medical devices.

• Collaborate closely with product development teams, including engineering, marketing, clinical investigations, and regional regulatory experts.

• Develop and implement regulatory strategies aligned with business objectives, including target markets, clinical claims, and timelines.

• Identify and define product testing and clinical study requirements to support regulatory submissions.

• Analyze and organize scientific data to demonstrate the safety and efficacy of medical devices.

• Prepare and submit regulatory documentation to authorities across global markets including the US, Canada, Latin America, Europe, China, and Asia.

• Provide regulatory guidance throughout the product development lifecycle to ensure compliance with international standards.

• Evaluate design changes and determine licensing or registration needs.

• Review and approve promotional materials to ensure alignment with regulatory claims.

• Monitor regulatory trends and communicate new requirements to internal teams.

• Support regulatory inspections and audits as needed.

Required Qualifications

• Advanced experience in Regulatory Affairs, ideally within the medical device industry, or advanced experience in product development within the medical device industry.

• Bachelor’s degree from an accredited university or college, or equivalent relevant experience.

• Strong analytical, problem-solving, and project management skills.

• Excellent oral and written communication abilities.

• Proficiency in English (written and spoken).

Preferred Qualifications

• Experience interacting with global regulatory agencies (e.g., FDA, Notified Bodies, NMPA).

• Knowledge of Quality Management Systems (QMS) and regulatory compliance frameworks.

• Proven ability to work independently in a fast-paced, dynamic environment.

• Adaptability to change and capability to drive positive transformation.

• Excellent team orientation and responsiveness to customer needs.

• Detail-oriented with a focus on delivering results.

• Experience working in multicultural and cross-functional teams.

Inclusion and Diversity

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.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

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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Additional Information