Senior Director, Regulatory Affairs - Monitoring Solutions

Job Description Summary

As the leader of a team of regulatory professionals, this position provides strategic regulatory leadership to the Monitoring Solutions business regarding regulatory requirements for product launch, market authorizations, and ongoing post market compliance requirements. You are an essential leader with the cross-functional business leadership team for the business in operations, and strategic planning.

GE HealthCare is a trusted global healthcare solutions partner, delivering advanced technologies, pharmaceutical diagnostics, and AI-powered tools that can help make hospitals more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Our mission is to create a world where healthcare has no limits. 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 deep domain expertise in regulatory areas critical to the Monitoring Solutions business including preparing sustainable plans to go to market and to stay on market for a diverse array of monitoring, life supporting, and life sustaining devices, understanding requirements for biocompatibility, reprocessing, medical software, cybersecurity, and dynamic market requirements.
• Leads a team of regulatory professionals in execution of regulatory affairs tasks in support of the businesses.
• Prepares global regulatory submissions by working across the regulatory organization and cross functionally with other functions such as Engineering, Clinical, and Research, and submits premarket submissions to regulatory authorities such as FDA, NMPA, PMDA, MFDS, EU CE Mark, etc., as per business’ timelines.
• Acts as an integrator to respond to postmarket inquiries from regulators and for postmarket obligations with product already on market.
• Researches, analyzes, integrates and organizes background information from diverse sources for regulatory submissions and strategic planning with leadership.
• Is an active member of external industry trade associations and/or standards organization and/or other relevant external groups to help shape regulatory requirements.
• Integrates complex and diverse programs, executing sound project management techniques, and is effective in both formal and informal influencing across the organization.
• Seeks out and implements proactive initiatives to improve and enhance the regulatory compliance and efficiency for the team and opportunities to learn in new scientific or technical areas important to the business.
• Responsible for team outcomes and deliverables, aligning priorities to match business objectives, supporting operating mechanisms with business counterparts, and best utilizing the skills of the team to optimize execution in the allotted time.

Required Qualifications

• Bachelor's Degree in a Scientific, Engineering, or other core Life Science discipline, or another complimentary discipline with a combination of training and experience demonstrating the equivalent.
• Demonstrated Regulatory leadership that enables top line growth in core, developing and emerging markets by supporting sustainability initiatives and product development.
• Deep expertise in multiple regulatory expertise areas to guide multi-modal strategies.
• Experience with high risk, life supporting, and life-sustaining products.
• A minimum of 15 years combined work experience in heavily regulated fields such as medical devices, pharmaceuticals, or biologics.
• A minimum of 10 years’ experience in Regulatory Affairs / Clinical Trials / Quality.
• A minimum of 5 years’ experience managing other technical employees, providing mentorship, and providing inputs to or managing budgets.
• A minimum of 5 years’ direct experience in regulatory project management/program management and regulatory agency interactions.
• Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening.

Desired Characteristics

• Advanced degree in Scientific, Engineering, Data Science, 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.
• Clinical data experience, including demonstration of valid scientific evidence supporting product safety and performance.
• Multi-disciplinary background allowing deep expertise in Regulatory Affairs while also integrating unique experiences from other roles to make a more comprehensive, informed, and strategic position for GE HealthCare.
• Excellent team leadership skills with global teams, facilitates teamwork, proven ability to lead and inspire.
• Demonstrated life-long learner; eagerness to obtain new skills and knowledge.
• Humility in understanding, but assertive when needed; willing to make difficult decisions and manage the organizational change required.

We will not sponsor individuals for employment visas, now or in the future, for this job opening.

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.