Quality Compliance / Regulatory & Medical Affairs (Director)

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募集要項

会社概要

同社は医療機器の販売やメンテナンス、医療機関向けのコンサルティングなど、医療分野に特化した大手外資系企業です。主要事業領域は、医療機器関連のサービスとソリューション提供で医療データの活用なども通じて、医療の発展に貢献しています。

業務内容

Main responsibilities:

• Maintaining a robust Quality Management System, ensuring compliance with Japan's Pharmaceuticals and Medical Devices Act (PMD Act) and other relevant regulations, acting as a General Controller for Marketing Authorization Holder (MAH).
• Communicate and execute Quality strategy in alignment with Global strategies
• Establish and manage the QA, QMS, PMS teams in Japan
• Establish and maintain appropriate QMS certifications, where applicable
• Report metrics for monitoring Quality Objectives / KPI, responsible for management review reporting.
• Coordinate and manage product registration files and business licenses in Japan, adhering to regulatory compliance requirements and timelines.
• Assist with Contract agreements when requested by legal, compliance, corporate contracting division and national accounts with regards to review and modification of quality based sections of the agreement.
• Build a cooperative relationship with competent Japanese authorities
• HR Management
  • Develop and manage staffing plans in the organization
  • To manage the decision-making process following the rules of authority.
  • Establish organizational talent strategy to include goals and objectives, performance and development and career and succession planning.
• Quality System Duties and Responsibilities
  • Build quality into all aspects of their work b

応募条件

Minimum requirements

• Education: Bachelor's degree (or Associate degree of Bachelor's) in science, engineering or related discipline is preferred.
• Extensive experience in establishing and managing compliance programs for medical devices and/or pharmaceuticals in the Japanese market.
• Proven experience working closely with Business, Marketing, Manufacturing, and R&D functions.
• Minimum 10 years' experience in Quality Assurance, Regulatory Affairs or Compliance management for Medical device company.
• Experience in managing all aspects of Quality and Regulatory Compliance in an international / global regulated healthcare environment, specifically in Japan, is preferred.
• Experience of successful interactions with global Quality and Regulatory teams
• Business level English skill to frequently communicate/discuss with upper management/ counterparts within the global/regional organization.
• Fulfill the eligibility criteria for Marketing Supervisor-General under Japanese regulation
• Ability to balance technical understanding of products and processes with compliance perspective.
• Demonstrated success in creating strategies to lead a team to success
• Must be thoroughly familiar with Japanese PMD Act (Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics), MHLW Ordinances, ISO 9001 and ISO 13485.
• Experience working with regulatory agencies, preferably with those in Japan, is required.
• Excellent communication and presentation skills, in both Japanese and English languages. 
• Pro-active, energetic, self-assured professional with the ability to develop good interpersonal relationships with other entities.
• A high degree of organization and the ability to meet ongoing deadlines
• Tenacity in following through on details
• Computer literacy, with a working knowledge of Microsoft Office products (e.g. Word, Excel, PowerPoint)
• Environmental consciousness and safe practices are exhibited in decisions
• Use computer and telephone equipment and other related office accessories/ devices to complete assignments
• May work extended hours during peak business cycles
• Travel requirements: The role requires domestic and international business travel. Travel anticipated to average 10% annually but may vary depending on project needs.

 

給与

1000 - 1660 万円

勤務地

東京