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General Electric Director, Regulatory Affairs - Women's Health and Xray in Wauwatosa, Wisconsin

Job Description Summary

You will provide strategic regulatory leadership to the Women’s Health (Mammography) and Xray (WHXR) Imaging business on regulatory requirements for product launch, submissions, and post-market compliance. You will lead a team of global regulatory professionals in preparing regulatory strategies, product development, pre-market submissions, post-market reporting and responses to regulator inquiries, regulatory intelligence, regulatory requirements flow-down and post-market compliance (e.g. advertising / promotion, etc.), as applicable. Supports the cross-functional business leadership team for the WHXR business in operations and strategic planning.

At GE Healthcare our passionate people are creating the products, solutions and services our customers need to deliver the best patient care possible.

Job Description

Essential Responsibilities

  • Provides high quality regulatory advice and is seen as a valued strategic partner to the business he / she supports

  • Leads a global team of regulatory professionals in execution of regulatory affairs tasks including global submissions and supporting product development in compliance with global regulations, in collaboration with cross-functional teams like engineering.

  • Provides deep domain expertise in regulatory areas critical to the business including medical software, medical electrical devices, radiation emitting devices, algorithms and artificial intelligence, and cybersecurity.

  • 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.

  • Researches, analyzes, integrates and organizes background information from diverse sources for regulatory submissions and strategic planning with leadership

  • Leads regulatory inspection support for sites, as well as support for regulatory inquiries from authorities related to adverse events or recalls.

  • Performs a broad variety of tasks in support of product and process design and support for regulatory and business leadership on operational and efficiency metrics

  • Supports and encourages a collaborative, inclusive, open and team- based culture across his / her organization. Provides mentorship and career growth opportunities to the regulatory team.

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

  • 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.

Qualifications/Requirements

  • Bachelor's Degree in a Scientific or Engineering discipline or a minimum of 10 years work experience.

  • 8 + years Regulatory Affairs / Quality Assurance experience

  • 8 + years experience in the medical device field

  • 5 + years experience of regulatory project management/program management and regulatory agency interactions

  • Strong experience with management of regulatory projects in global regulatory organizations and working globally and across different cultures

  • 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.

Desired Characteristics

  • People management experience

  • Experience preferred with imaging or high risk devices

  • Advanced degree in scientific, technology or regulatory affairs disciplines

  • Regulatory Affairs Certification (RAPS)

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

  • Ability to make sound business judgments both with independence and knowing when to seek advice and support

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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

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer (https://assets.phenompeople.com/CareerConnectResources/GE11GLOBAL/en_global/desktop/assets/images/poster_screen_reader_optimized_w_supplement.pdf) . 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 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).

As a federal government contractor, GE may in the future be required to have U.S. employees fully vaccinated against COVID-19. Some GE customers currently have vaccination mandates that may apply to GE employees.

Relocation Assistance Provided: No

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