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About the Role

As the head of RAQA (Regulatory Affairs and Quality Assurance), you will lead the establishment and maintenance of systems and organizations to ensure the quality, efficacy, and safety of medical devices. This is a critical role supporting business growth and maximizing customer value.

Responsibilities

• Establish and continuously improve systems and processes to ensure the quality, efficacy, and safety of medical devices.
• Develop and operate systems to ensure product functionality, safety, and efficacy as the technical lead for product introductions.
• Promote the strengthening of RAQA and systems from an overall optimization perspective, ensuring compliance with regulations and quality requirements.
• Lead quality and regulatory affairs strategies to maximize customer value, based on Medline's philosophy and mission.
• Foster organizational culture, develop talent (including succession planning), and maximize team performance.
• Promote risk management and lead continuous improvement of business processes.
• Establish and maintain QA/RA organizational structures based on laws and industry standards.
• Foster an organizational culture that reflects Medline's philosophy and mission.
• Promote the development and skill enhancement of department members.
• Develop and execute succession plans for successors.
• Establish and maintain QMS and GVP systems for medical device manufacturing and sales.
• Conduct self-inspections, external audits, and improvement activities in response to regulatory authorities (PMDA, etc.).
• Maintain and improve strategic introduction/change systems in accordance with business strategy.
• Ensure appropriate product functionality, safety, and quality (determine appropriate quality requirements with the marketing department, and develop and implement quality assurance programs in cooperation with suppliers, manufacturing partners, and the marketing department).
• Monitor, manage, and collaborate with suppliers to ensure stable product quality.
• Strengthen collaboration between Medline Global and Japan, related departments, and external stakeholders.
• Promote process improvements by eliminating waste and risks from an overall optimization perspective.
• Set RAQA department goals (regulatory affairs, quality assurance, efficiency) and implement strategies to achieve them.
• Contribute to business risk management, problem-solving, and profit improvement as the RAQA department.

Requirements

• Bachelor's degree in Engineering, Science, or Technology.
• Over 10 years of experience in Quality Assurance (QA) or Regulatory Affairs (RA) in the medical device industry.
• Experience collaborating with domestic and international suppliers and regulatory authorities.
• Experience working for a company with its own manufacturing plant.
• Experience with consumer (or disposable) products.
• 5 or more years of team management or project leadership experience.
• Knowledge and qualifications related to ISO13485 and the Pharmaceutical and Medical Device Act are desirable.
• Ability to set and execute strategies for business goals (regulatory affairs, quality assurance, efficiency).
• Data analysis and reporting skills to identify problems, trends, and exceptions, and to find solutions for improvement.
• Ability to manage and coordinate multiple projects, competing priorities, and critical deadlines.
• Knowledge and experience in product introduction (including building balanced quality requirements).
• Ability to guide and develop subordinates and formulate and execute succession plans.
• Ability to manage and evaluate organizational activities.
• Ability to collaborate with internal and external stakeholders to identify, share, and promptly resolve issues.
• Ability to build industry networks and strengthen relationships with other companies.
• Decision-making and action from a management perspective.
• Ability to propose and execute measures contributing to business strategy and performance improvement.
• Executive Business English proficiency (reading, writing, and speaking).
• Must submit a resume and work history in PDF format when applying.

Skills

• QMS
• GVP
• ISO13485
• Pharmaceutical and Medical Device Act knowledge and practical experience
• Data analysis
• Project management
• Product introduction
• Team management
• Succession planning
• Organizational management
• Stakeholder collaboration
• Problem-solving
• Strategic thinking
• Executive Business English

Location

• Sumitomo Fudosan Korakuen Bldg. 15F, 1-4-1 Koishikawa, Bunkyo-ku, Tokyo 112-0002, Japan

Work Type

• Full-time
• Hybrid (Flex time system available)

Experience Level

• 10+ years in QA or RA in the medical device industry
• 5+ years in team management or project leadership

Education Level

• Bachelor's degree in Engineering, Science, or Technology

Benefits

• Salary increase once a year
• Bonus once a year (varies by performance)
• Commuting allowance (according to company regulations)
• Retirement plan
• Housing allowance system
• Welfare service (Benefit Station)
• Health support: Full subsidy for influenza vaccination and health check-up costs
• Company-designated holiday (1 day)
• Social insurance (Employment, Workers' Compensation, Health, Pension)
• No smoking indoors

About the Company

• Medline Japan LLC is the Japanese subsidiary of Medline Inc.
• We manufacture and sell medical devices and supplies such as surgical prep kits, non-woven products like gowns and drapes, operating room related products, surgical and examination gloves, personal protective equipment, respiratory therapy products, and vascular catheter related products for medical institutions.
• In Japan, we have our Tokyo headquarters, branches and sales offices in major cities, as well as a surgical prep kit factory, distribution center, and sterilization center.
• Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care.
• Through its broad product portfolio, resilient supply chain and leading clinical solutions, Medline helps healthcare providers improve their clinical, financial and operational outcomes.
• Headquartered in Northfield, Illinois, the company employs more than 43,000 people worldwide and operates in more than 100 countries and territories.
• Learn more at www.medline.com.