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Senior Ra and QA Manager Mexico
hace 3 meses
Job Description Summary:
GE Healthcare is a leading global innovator in medical technology and digital solutions with more than 100 years of experience in the healthcare industry and approximately 50,000 employees worldwide.
Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally.
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 globally
- 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 mínimal 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.
- 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.
- Act as Sanitary Responsible in Mexico.
- Assure the Quality System is under compliance with internal and external requirements.
- Represent the company with Trade Associations, monitoring the regulatory environment.
Required Qualifications
- Chemical degree or similar
- 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 ( or a high school diploma with relevant experience).
- Medical Devices Regulatory experience in Mexico is required.
- At least 10 yers of experience in regulatory affairs
- English advanced
This means that all decisions are made regardless of race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability or other characteristics protected by the law.
We expect all employees to live and breathe our behaviors: act humbly and build trust; lead with transparency; Deliver with focus and drive ownership, always with unwavering integrity.
Our total rewards are designed to unlock your ambition by giving you the momentum and flexibility you need to turn your ideas into world-changing realities.
Our salary and benefits are everything you would expect from an organization with global scale and strength, and you will be surrounded by career opportunities in a culture that encourages caring, collaboration and support.
LI-KL1Additional Information:
Relocation Assistance Provided:
Yes
