RA/QA Specialist

Job Overview

Post Date
Job Function

About the Position

  • Products registration for new products of IVD and medical device

  • Applications for reimbursement points (E3/E2 category)

  • Maintenance of approvals, certifications and registrations (Periodical renewal and Change control)

  • Audits/inspections, yearly surveillance, QMS compliance inspection applications and QMS conformity to control, manage and review.

  • Documentation preparation for regulatory package inserts, product labeling, regulatory training, standards, regulation tracking, and translations.

  • Role as “Hinseki” of medical device or “Anseki” of medical device and/or IVD upon request

  • Post marketed activities including complaint evaluation, complaint registration, medical device reporting, vigilance reporting, product correction, removals, and recalls.

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