|職務内容||〇 Assumes the role and responsibilities of QA management in the areas of quality assurance, Safety control (preferable) and Quality Affairs Specialist for Cutera KK
〇 Collect, provide and analyze quality and safety information; create SOPs and documents; create and retain quality records,
〇 Support complaint handling and an effective complaints management process
〇 Works as the Post-Marketing Safety Controller to ensure processes are compliant and reporting to the authorities with Good Vigilance Practice.
〇 Ensures the safety and quality activities meet customer, Corporate, and internal requirements as well as any other related requirements within the Quality Management System.
〇 Coordinates with Cutera Headquarters for investigation, product disposition, management or support of deviations, change control, and NC/CAPA processes related to safety issues throughput the product life cycle.
〇 Develops, reviews, and approves Good Vigilance Practice documents to ensure compliance with applicable regulations, product laws, and corporate requirements
〇 Manages and/or performs internal and external Good Vigilance Practice compliance audits/inspections as well as participate in management of corrective action program, in line with global standards.
〇 Maintains current knowledge, excellent comprehension, and appropriate application of relevant regulations.
〇 Communicates with and updates Cutera headquarters management teams on a regular basis.
|応募資格||〇 University degree (preferable), BS (preferable)
〇 At least three years of experience in safety control work and meet other requirements required for Safety Management Controller of Medical Device under the law. (Experiences in Regulatory Affairs is a plus.)
〇 Fluent communication skill in English (mainly by e-mail and sometimes face-to-face/phone conference)
〇 An understanding of relevant GVP regulations and requirements, as well as ISO 13485 and/or ISO 9001