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
INSIGHTEC LTD. is the approval holder INSIGHTEC neuro device in Japan and INSIGHTEC JAPAN is appointed by INSIGHTEC LTD. as Designated Marketing Authorization Holder (DMAH) as distributors of INSIGHTEC neuro device in Japan. This position will be responsible for Post Marketing Safety Control defined in GVP ordinance #135. This position will require communicating with PMDA/Tokyo Metropolitan Government (TMG).
- 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
- Analyse safety information collecting form literature and related Conferences.
Skills and Experience:
- S. or B.A. degree in scientific or technical discipline. Advanced degree preferred.
- Experience to create STED
- Class II medical device, Class III medical device is preferable.
- Knowledge/experience with QMS/ISO13485 is preferable
- Meet the requirements on Safety Controller
- Apply business and Safety ethical standards
- Multitask and manage multiple projects to meet deadlines
- Work with cross-functional teams (located in JP)
- Communicate effectively in writing (English/JP) as well as with team members from various cultural backgrounds, verbal English communication is preferable.
- Ability to foster relationships with regulatory agencies, TMG consultants and colleagues
- Write, review, and prepare complex documents (English/JP)
- Think analytically and critically
- Proficient with Microsoft Office
- Ability to travel both domestically and internationally is required
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