APAC Regulatory Affairs Lead
What you will be doing
- Working according to Insightec Quality Policy, relevant Quality Procedures & Standards, and privacy & safety rules.
- Preparation and maintenance of regulatory submissions and registrations of INSIGHTEC devices to PMDA/ARCB.
- Preparation and maintenance of regulatory submissions and registrations of INSIGHTEC devices in APAC countries (e.g. Taiwan, Singapore, Korea, India, SEA), directly with authorities or via local agents.
- 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
What you have
- 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
- B.Sc. or B.A. degree in scientific or technical discipline. Advanced degree preferred.
- Experience to create STED
- Experience with Class II and Class III medical device in Japan and preferably also in Taiwan, Korea, ,
- Knowledge/experience with QMS/ISO13485 is preferable
Other Requirements:
- Ability to travel both domestically and internationally is required
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