RAQA/Product Development Director

Job title: RAQA/Product Development Director

About the Role The RAQA Director will lead the establishment and ongoing maintenance of quality and regulatory systems to ensure the safety, effectiveness, and regulatory compliance of Medline's medical devices in Japan. As head of RAQA, you will drive the quality and regulatory strategy aligned with Medline's mission, supporting business growth and customer value.

What You'll Do

• Build and maintain QA/RA organizational structure in accordance with laws and industry standards; cultivate a culture aligned with Medline's mission and values.
• Lead leadership and talent development, coaching, and succession planning; identify and develop successors.
• Manage QMS, GVP, internal/external audits, regulatory agency responses (PMDA, etc.), and continuous improvement activities.
• Develop product introduction/changes strategy aligned with business goals; ensure product functionality, safety and quality; coordinate with marketing, suppliers, manufacturing partners on QA programs.
• Monitor suppliers, manage collaborations to ensure stable product quality; drive global–Japan alignment and cross-functional process improvements to minimize waste and risk.
• Contribute to business risk management and strategic objectives of the RAQA function; set department goals and drive execution.

What We're Looking For

• Bachelor's degree in engineering, science or technology; 10+ years' experience in QA or RA for medical devices; experience with domestic and international suppliers and regulatory authorities; experience in a company with its own manufacturing site; experience with consumer/disposable products; 5+ years of team management or project leadership.
• Knowledge of ISO13485 and 薬機法; experience with QMS, GVP and product introductions; ability to lead regulatory affairs and quality initiatives.
• Strong leadership and people development capabilities; track record of building high-performing teams.
• Excellent communication and problem-solving skills; ability to collaborate with internal and external stakeholders and build industry networks.
• Strategic thinking and business acumen; executive-level English proficiency (read/write/speak).

Nice to Have

• Data analytics for target setting and problem solving; experience in product introduction and risk-based qualification; ability to manage multiple projects with competing priorities and deadlines.
• Leadership and management skills; succession planning and performance management.
• Global/regulatory liaison experience; strong stakeholder management and relationship-building.
• Language proficiency: Executive-level English.

Compensation & Benefits

• Salary: not disclosed; annual salary with annual pay raise; annual bonus depending on performance.
• Benefits: transportation allowance (per policy), retirement benefits, tax-advantaged savings program, benefits program (Benefit Station), health support including full coverage for flu vaccines and health checkups.
• Holidays and insurance: company-designated holidays, fully insured social insurance (employment, workers' compensation, health, pension); paid leave and special leave; 126+ annual holidays.
• Other: flexible working hours (core time 10:30-15:00); working hours 9:00-17:30; hybrid work arrangement; 60-minute break.