Program Manager - Regulatory Affairs in Maternal and Infant Care

Program Manager, Regulatory Affairs, Maternal Infant Care

Job Description Summary

Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post-market compliance, working closely with healthcare regulatory bodies globally. Has knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the market

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

• Provides regulatory strategy and direction for the MIC business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post-market compliance, working closely with healthcare regulatory bodies globally.

• Prepares global regulatory submissions by working across the regulatory organization and cross functionally with other functions such as Engineering, Clinical, and Scientific, and submits premarket submissions to regulatory authorities such as FDA, EU, NMPA, PMDA, MFDS, CDSCO, etc., as per business’ timelines.

• Assesses changes in existing products and determines the need for new / revised licenses or registrations.

• Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.

• Is an active member of external industry trade associations and/or standards organization and/or other relevant external groups to help shape regulatory requirements.

• Proven interpersonal skills. Communication with direct colleagues and the business about design and coordination services rendered. Provides informal guidance to new team members. Explains complex information to others in straightforward situations.

Required Qualifications

• Bachelor's degree in a Scientific, Engineering, Computer Science, or other core Life Science discipline, or a combination of training and experience demonstrating the equivalent.

• A minimum of 6 years combined work experience in heavily regulated fields such as medical devices, pharmaceuticals, or biologics.

• A minimum of 5 years’ experience in Regulatory Affairs.

• A minimum of 5 years’ experience in regulatory agency interactions and regulatory project management.

• Prepares global regulatory submissions by working across the regulatory organization and cross functionally with other functions such as Engineering, Clinical, and Scientific, and submits premarket submissions to regulatory authorities such as FDA (with specific experience authoring US FDA 510(k)'s) , EU, NMPA, PMDA, MFDS, CDSCO, etc., as per business’ timelines.

• Excellent verbal and written communication and presentation skills with the ability to speak and write clearly and convincingly in English, tailoring communication methods to customer’s requirements.

• Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and collaboration applications.

Desired Characteristics

• Experience with Software (SiMD or SaMD), cybersecurity, and other non-device software products.

• Experience with Biocompatibility standards and regulator expectations.

• Experience with high risk, life supporting, and life-sustaining products.

• Advanced degree in scientific, technology or regulatory affairs disciplines.

• Regulatory Affairs Certification (RAC) issued by the Regulatory Affairs Professionals Society (RAPS).

• Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial, or political situations and their impact on GE Healthcare regulatory strategies.

• Demonstrated life-long learner; eagerness to obtain new skills and knowledge.

• Humility in understanding, but assertive when needed; willing to make decisions and assign clear priorities.

• Proven track record of strong collaborative skills with key partners, such as engineering and commercial

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.

Additional Information

Relocation Assistance Provided: No

Experience Level

Mid Level