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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