Director, Regulatory Intelligence and Policy, PDX

Job Description SummaryProactively monitors and analyzes regulatory intelligence and policy developments relevant to Pharma/Bio Pharma innovations; leads regulatory strategy and policy positions; engages in external advocacy/influencing opportunities to drive GE HealthCare policy objectives and to ensure policies, regulations and guidance include GE HealthCare input. Develop external relationships with regulatory authorities and other industry stakeholders. Inform business and regulatory strategies across product portfolios and lifecycles.

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

• Proactively monitor external regional and global sources for Regulatory Intelligence and Policy developments relevant to Pharma/Bio Pharma innovations and other innovative areas of importance to GE HealthCare.
• Assess the relevance and impact of regulatory intelligence information to GE HealthCare's products, processes, regulatory strategies, and market strategies.
• Communicate effectively with internal and external stakeholders on business critical aspects of regulatory intelligence.
• Collaborate with GE HealthCare regulatory teams across key markets to drive a proactive and consistent approach to monitoring of local environment and policy changes, and to ensure GE HealthCare has the opportunity to shape policy through proactive engagement and commenting opportunities.
• Work collaboratively with the Global Regulatory Intelligence & Policy team to maintain an effective strategy for external influencing engagement with trade associations, regulators, and other relevant stakeholders on the regional and global level to ensure GE HealthCare's voice and priorities are included in the development of future policy, regulations and guidance.
• Routinely engage and build relationships with a range of internal and external stakeholders, including cross-functional SMEs, trade associations, regulators, and other relevant industry stakeholders.
• Inform and influence others (internal and external) to find creative and strategically aligned solutions to address regulatory changes and/or complex issues that may impact GE HealthCare.

Required Qualifications

• Bachelor's Degree in a Scientific or Engineering discipline
• A minimum of 7 years Regulatory Affairs / Quality Assurance experience in the pharmaceutical industry or regulator
• Experience developing regulatory strategies and leading regulatory agency interactions
• Experience with project management across global teams
• Excellent verbal and written communication and presentation skills

Desired Characteristics

• Advanced degree in scientific, technology or regulatory affairs disciplines
• Ability to work in a matrix environment and engage relevant stakeholders.
• Strong leadership,  interpersonal, collaboration and influencing skills
• Demonstrated ability to build relationships internally and externally
• Demonstrated understanding of healthcare environment and knowledge of current industry, competitive, and political situations as well as impact

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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For U.S. based positions only, the pay range for this position is $148,000.00-$222,000.00 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.

Additional Information

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.

Relocation Assistance Provided: No

Application Deadline: April 04, 2025 Apply