This healthcare organization is committed to advancing innovative solutions that support better patient outcomes and strengthen the future of medical care. With an international perspective and a focus on quality, compliance, and responsible innovation, the company offers an environment where specialists can make a meaningful contribution to a growing business.
Employees are encouraged to collaborate across functions, bring thoughtful expertise to complex challenges, and uphold high standards in everything they do. This is an opportunity to join a purpose-driven organization where regulatory and quality professionals play an important role in enabling trusted healthcare solutions.
As a Senior Specialist, Regulatory Affairs and Quality Assurance (RAQA), you will support the organization’s regulatory compliance and quality management activities in Japan. Based in Tokyo, you will help ensure that products, processes, and documentation meet applicable requirements and internal standards.
Your responsibilities will include supporting regulatory submissions and communications, maintaining quality documentation, contributing to inspections and audits, and partnering with internal stakeholders to address compliance matters. You will also help identify opportunities to strengthen processes, manage risks, and promote a consistent culture of quality across the organization.
This permanent position is suited to a detail-oriented professional who can work independently while collaborating effectively with cross-functional and international teams.
Professional experience in regulatory affairs, quality assurance, or a related function within the healthcare, medical device, diagnostics, pharmaceutical, or life sciences sector.
Strong understanding of applicable regulatory and quality requirements in Japan.
Experience preparing, reviewing, and maintaining controlled documentation and compliance records.
Ability to support regulatory submissions, audits, inspections, and quality-related investigations.
Strong attention to detail and a disciplined approach to documentation, process management, and follow-through.
Excellent communication and stakeholder-management skills, with the ability to work effectively across functions and cultures.
Ability to assess issues, identify practical solutions, and escalate risks appropriately.
Proficiency in written and spoken Japanese and English to support local and international collaboration.
Bachelor’s degree or equivalent professional qualification in life sciences, healthcare, engineering, or a related field.
