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Role Summary: As the Safety Officer for GE Healthcare Japan (GEHC-J), this person will lead the post market regulatory team in Japan and will be responsible for all post market regulatory activities required by Japanese law for this position. He/she will work with global and central counterparts, according to GEHC policies and procedures for all post market matters.
Essential Responsibilities: 1. Leads the post market regulatory team in Japan in compliance with post market regulatory activities required by Japanese law 2. Assesses adverse events and field actions for reportability to Japan regulators and prepares and submits reportable events and recalls in a timely manner and in compliance with Japan medical device regulations. 3. Works collaboratively and cross functionally with global and central counterparts, per GEHC policies and procedures for all post market matters. 4. Monitors the regulatory environment for post market changes, works with global and central counterparts at GEHC to develop positions and help shape requirements, flows down changes through GEHC communication mechanisms in a timely manner. 5. Supports regulatory inspections as required. 6. Performs other tasks and as assigned by department leadership.
Qualifications/Requirements: 1. Minimum of 3 years’ experience in the post market safety management/ANSEKI qualification. 2. Ability to communicate effectively in Japanese and English (both written and verbal). 3. Bachelor's Degree or a minimum of 4 years’ work experience. 4. Minimum of 1 year experience working in healthcare industry. 5. Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications.
Desired Characteristics: 1. Minimum of 5 years’ experience medical device industry 2. Advanced degree in scientific, technology or legal disciplines 3. Demonstrated ability to work cross functionally and globally 4. Statistics education and or training 5. Ability to work independently in fast-paced environment with little supervision 6. Ability to adapt to constant change and influence positive change effectively 7. Team-oriented and responsive to customer needs 8. Attention to Detail and Results-Oriented 9. Ability to understand technical documentation and execute associated procedures
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