・Applicants must have permission to work in Japan
・Applicants must be able to speak fluent ~ native level Japanese (Equivalent to JLPT N1)
☑外資系企業 ☑英語力が必要 ☑リモートワーク可能 ☑ハイブリッド（出社×リモートワーク）
Director, Regulatory Affairs and Quality Assurance
This position is responsible for managing the regulatory affairs and quality assurance functions. Acquiring regulatory approval of advanced medical device products and handling product complaint issues are an especially important mission, as well as securing global consistency of the RA & QA functions by closely collaborating with the Global RA & QA teams.
A. Regulatory Affairs
➢ Maintain and renew Marketing Authorization Holder License and other licenses based on Pharmaceutical Affairs Law in Japan with proactive communication of cross functional support needs.
➢ Work effectively with the Global RA team to manage medical device safety reporting.
➢ Acquire regulatory approval of advanced (Class Ⅱ&Ⅲ) medical device products as soon as scheduled through thoughtful strategy development, effective communication with both external and internal partners, and productive agency interface with governmental organization, such as Tokyo Metropolitan Government/Ministry of Health, Law and Welfare (MHLW).
➢ Serve as a liaison between Japanese management and Global RA representatives.
B. Quality Assurance
➢ Develop/maintain quality system/programs consistent with local laws/regulations and when necessary, tackle and resolve compliance issues.
➢ Effectively handle product complaint issues by analyzing the cause of issues, creating complaint report for customers and when necessary, communicate with customers with sincerity.
➢ Ensure that product repackaging operations in the warehouse comply with quality and regulatory requirements.
➢ Provide executive management team with valuable business insights/suggestions/technical training (RA/QA) as a member of the team.
➢ Serve as a liaison between Japanese management and Global QA representatives.
C. Promotion material Approver
➢ Ensure scientific reliability of promotion material as local final approver
D. Safety control manager
➢ Responsible for safety issues and information
➢ Ensure reliable reporting of adverse incidents to MHLW
➢ Liaise with Global Compliance Officer with respect to issues involving bribery, competition, and privacy.
➢ Monitor and advise Global RA & QA on proposed and existing legislation and regulatory developments affecting Japan's business.
➢ Maintain and improve QA functions by creating/updating SOPs, Rules & Policies etc.
➢ Drive staff development and regulatory and quality assurance experience while setting expectations for organizational support and strategy creation/execution.
➢ Other duties and tasks as assigned by President.
Work Experience Requirements
➢ Minimum of 5 years of both RA & QA experience at global medical device/healthcare company, including regulatory submission experience and 5 years of management experience.
➢ Demonstrated experience successfully working with the PMDA and local regulatory authorities on execution of medical device registration strategy
➢ Bachelor in either of Science, Chemical, Mechanical, Pharmaceutical or Dental etc. Specific educational background is required to be qualified as a "General Marketing Supervisor of Medical Devices" based on Japanese Pharmaceutical Affairs Law (General Marketing Supervisor of Medical Devices qualification is mandatory for this position) *General Marketing Supervisor of Medical Devices 医療機器等総括製造販売責任者
➢ MSc, Pharmacist, PhD (preferred)
Specialized Skills/Technical Knowledge:
➢ Extensive knowledge about Japanese PAL.
➢ Excellent communication skills and strong negotiation skills.
➢ Business level English at speaking, writing and understanding.
➢ Excellent organizational skills, with timely responsiveness to internal and external customer group
➢ Result oriented
➢ Problem solving
➢ Experience of managing external regulatory audit
Seniority Level: Director
Job Function: Quality Assurance, Management