Program Manager, Regulatory Affairs, Anesthesia & Respiratory Care

Job Description

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.

Roles and Responsibilities :

• Provides regulatory strategy and direction for the ARC 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 :

Desired Characteristics :

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.

For U.S. based positions only, the pay range for this position is $103,200.00-$154,800.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and / or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.

GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. 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. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.