Regulatory Specialist & Safety Controller-Japan
Regulatory Affairs (approximately 70% workload)
- Preparation and maintenance of regulatory submissions and registrations of INSIGHTEC devices to PMDA/ARCB according to Regulatory & Quality Affairs Manager, Japan
- Development of annual Post Market Survey (PMS) reports to PMDA, and develop a submission document for re-evaluation on applicable INSIGHTEC devices based on data reports by CRO
- Information collection of an amendment of local premarket regulatory requirements
- Interpretation of local regulator rules or rule changes and ensure that they are communicated through corporate policies and procedures
- Work closely with various teams of Country manager reporting lines (CRO, Applications, CAM, Marketing) located at the INSIGHTEC Japan office
- Perform other duties RA associated as required
Safety Control (approximately 30% workload)
- In collaboration with INSIGHTEC LTD, review of customer complaints to determine regulatory reportability to PMDA, report as applicable and document these actions.
- Maintain/Develop INSIGHTEC Japan company procedure related Safety Control/Vigilance in compliance with all applicable Japan guidelines and regulations, and in-line with INSIGHTEC Safety procedures.
- Partner with Headquarters Vigilance team for better operation as Domestic Safety role & responsibilities.
- Training on Medical Device Safety Control/Vigilance for IJ employee
Skills and Experience:
- B.Sc. or B.A. degree in scientific or technical discipline
- 2-3 year experience of Regulatory Affairs.
- Experience to create STED
- Class II medical device, Class III medical device is preferable.
- Knowledge/experience with QMS/ISO13485 is preferable
- Apply business and Safety ethical standards
- Work with cross-functional teams (located in JP)
- Ability to foster relationships with regulatory agencies, TMG consultants and colleagues
- Write, review, and prepare complex documents (English/JP)
- Think analytically and critically
- Ability to travel both domestically and internationally is required
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エクサブレート・ニューロ（Exablate Neuro）は販売名「MRガイド下集束超音波治療器 ExAblate 4000」のことです。