Regulatory Affairs Manager (Global Healthcare Company)

A senior people-management role leading the regulatory function for a global healthcare company's in-vitro testing business in Japan. The role owns regulatory strategy across the full product lifecycle and is the main contact for the health authorities.

• Set and execute the regulatory strategy for new product launches and the existing portfolio, joined up with reimbursement and market-access planning
• Lead approval applications, authority consultations and negotiations, including with the regulator and the ministry
• Manage post-approval changes, labeling and promotional-material review, and regulatory risk over the product lifecycle
• Oversee overseas manufacturer registration and quality-system inspection readiness together with Quality Assurance
• Build and coach the regulatory team, and act as the regulatory voice in cross-functional projects and with the global organization

• 5+ years of regulatory affairs experience in medical devices or in-vitro testing products, including leading an approval project
• Experience negotiating with the Japanese health authorities; people-management experience (3+ years preferred)
• Strong knowledge of the Japanese pharmaceutical and device regulations and of regulatory strategy
• Business-level English (around TOEIC 700), including experience presenting to a global head office
• Bachelor's degree or above; a life-science or medical-technology background is preferred
• Preferred: companion-test approval experience, involvement in reimbursement strategy, Quality Assurance or Clinical Affairs background