Job Information
GE Healthcare Director - Regulatory Affairs, Japan in Hino, Japan
Job Description Summary
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 in Japan. Interprets simple internal and external business challenges and recommends best practices to improve products, processes or services. Stays informed of industry trends that may influence work.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose 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 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 in Japan such as PMDA and MHLW.
Manages a team of senior regulatory affairs professionals. Requires specialized depth and/or breadth of expertise within their discipline. May require strong commercial awareness, and is expected to influence the development of strategy within own area, including control of resources and influences policy formulation.
May lead functional teams or projects with minimal resource requirements, risk, and/or complexity. Communicates difficult concepts and may influence others' options on particular topics. May guide others to consider a different point of view.
Impacts the team's ability to achieve service, quality and timeliness of objectives. Work is subject to functional policy objectives. Regularly advises management in the function and/or in the business. Has a supportive role in decision making about important subjects. High levels of evaluative judgment are required to achieve outcomes required.
Uses high level of judgment to make decisions and handle complex tasks or problems that impact the function. Has ability to assess quality of information given and ask pertinent questions to stakeholders. Able to offer new solutions to problems outside of set parameters and is able to construct and provide recommendations. Uses multiple internal and some external sources outside of own function to help arrive at a decision.
On the staff of the CEO of GE HealthCare Japan and advises the senior leadership team on regulatory compliance matters.
Required Qualifications
This role requires significant experience in the Quality & Regulatory Affairs. Knowledge level is comparable to a Master's degree from an accredited university or college.
15+ years of experience in leading medical device companies in leadership positions, experience working with regulatory agencies and notified bodies is a must. Experience in advocacy is considered a bonus.
Fluency with both English and Japanese language.
Desired Characteristics
Strong oral and written communication skills.
Strong interpersonal and leadership skills.
Demonstrated ability to analyze and resolve problems.
Demonstrated ability to lead programs / projects.
Ability to document, plan, market, and execute programs.
Established project management skills.
Additional Information
Relocation Assistance Provided: No