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Primary Function:
- Execute the regulatory strategy for obtaining registration approval of Intuitive’s portfolio.
- Coordinate with Distributor RA to compile regulatory documentation for submissions.
- Evaluate medical device changes and determine regulatory strategy.
Essential Job Duties:
- Work with BU RAs to execute registration plans in APAC indirect markets.
- Communicate with stakeholders to ensure compliance with medical device regulations.
- Input and manage submission tracking in regulatory databases.
Qualifications:
- 5-10 years experience in medical device registration in ASEAN countries.
- Bachelor's degree in Medical Technology, Life Sciences, or similar.
- Knowledge of ISO13485 and quality management systems.
Intuitive
Intuitive is a pioneer and market leader in robotic-assisted surgery, dedicated to advancing minimally invasive care. The company has built an inclusive and diverse team of great people for over 25 years, grounded in integrity and a strong capacity to learn.