JOB DESCRIPTION SUMMARY

A trusted regulatory subject matter expert to provide guidance to the GE HealthCare Monitoring Solutions business focused primarily on patient monitoring in cardiac, respiratory, neurology, hemodynamic, and pulse oximetry. You will work within a team of Regulatory Affairs professionals to ensure GE HealthCare establishes best practices in compliance with regulatory requirements. The Lead Regulatory Affairs Specialist will be involved with regulatory activities in the areas such as premarket submissions, regulatory intelligence, regulatory requirements flow-down, advertising and promotion review, product labeling compliance, etc.
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.

QUALIFICATIONS/REQUIREMENTS:

• Bachelor’s degree from an university or college, preferred in a Scientific, Engineering, Regulatory, Legal, or core Life Science discipline.
• 2 to 5 years’ experience in a highly regulated industry, preferred in Regulatory Affairs, or equivalent experience through advanced degree or other relevant education and experience.
• Strong verbal and written communication, and presentation skills, with the ability to speak and write clearly and convincingly in English.
• Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and collaboration applications.

• Provide regulatory input for product development to ensure compliance to regulatory requirements for target markets. Develop regulatory strategies to help guide 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.
• Work with a cross functional team to prepare and submit regulatory submissions such as 510(k)s, MDR EU Technical Files, or submissions to other global regulators such as NMPA, TGA, etc., for the purpose of obtaining authorization for market launch.
• Assess changes in existing products to and determine the need for new / revised licenses or registrations. Develop plan for timely submission of renewal registrations for applicable countries per business plan, to ensure continued product supply in those countries.
• 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.
• Ensure compliance with pre- and post-market product approval requirements.
• Support regulatory inspections, as required.
• Perform necessary registrations and notifications to perform clinical studies.