Regulatory Specialist & Safety Controller-Japan

Responsibilities:

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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