Director, Quality & Regulatory Business Development-2

GE HealthCare•Waukesha, WI

About The Position

GE Healthcare is a leading global medical technology and digital solutions innovator with a mission to improve lives. This Director role focuses on managing, analyzing, integrating, and improving business development capabilities within the Quality & Regulatory domain. The position involves developing and maintaining systems, rules, and processes to ensure fulfillment of internal and external requirements, ensuring projects and products meet specified standards. The Director will interpret internal and external business challenges, recommend best practices to improve products, processes or services, and stay informed of industry trends. The role is expected to influence strategy development within the functional area, including control of resources and input into policy formulation, and may lead functional teams or projects.

Requirements

Master’s degree with a minimum of 5 years of experience in the medical device industry; or Bachelor’s degree with a minimum of 10 years of experience in the medical device industry; or High School Diploma with a minimum of 15 years of progressive responsibility in the medical device industry.
Experience with medical device QMS and regulatory requirements, including but not limited to FDA 21 CFR Part 820 and ISO 13485.
Minimum of 5 years of experience directly driving global programs to resolve quality compliance issues.
Legally authorized to work in the United States for this opening.
Successful completion of a drug screen (as applicable).

Nice To Haves

Demonstrated ability to lead programs and projects.
Ability to document, plan, market, and execute programs.
Established project management skills.
Demonstrated ability to analyze and resolve problems.
ASQ certification (CQE, CQA, etc.) and/or Lean certification (Green Belt, Black Belt) preferred.
Ability to translate strategy into specific actions with clear accountability; make decisions with speed and accuracy based on the best available information; and communicate priorities clearly and concisely.
Ability to interface with senior organizational leadership and internal and external customers in a professional manner.
Ability to energize others by building strong team connections through personal involvement and trust, providing feedback and coaching, and driving accountability.
Strong oral and written communication skills in English.
Integrity: Accepts and adheres to high ethical, moral, and personal values in decisions, communications, and actions.
Ability to travel domestically and internationally up to 20%.

Responsibilities

Manage, analyze, integrate and improve business development capabilities.
Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements.
Ensure that projects and products are capable and will meet specified standards.
Interpret internal and external business challenges and recommend best practices to improve products, processes or services.
Stay informed of industry trends that may influence work.
Develop, implement, and monitor overall process mapping for quality improvement purposes.
Drive standardization of processes, tools, and performance management systems.
Influence strategy development within the functional area, including control of resources and input into policy formulation.
Lead functional teams or projects with minimal resource requirements, risk, and/or complexity.
Communicate difficult concepts and may influence others’ opinions on particular topics.
Guide others to consider different points of view.
Regularly advise management within the function and/or the business.
Maintain a supportive role in decision-making on important matters.
Use a high level of judgment to make decisions and manage complex tasks or problems that impact the function.
Assess the quality of information provided and ask pertinent questions of stakeholders.
Develop novel solutions outside of established parameters and construct well-reasoned recommendations.
Utilize multiple internal and some external sources outside of the immediate function to inform decision-making.