Head of Regulatory Affairs, Japan

A top tier global medical device company seeking an experienced Head of Regulatory Affairs for Japan to lead regulatory strategy and execution across the Japan business. This is a critical leadership role responsible for ensuring regulatory compliance, driving timely product approvals, and partnering closely with global and regional stakeholders to support business growth in Japan.

Key Responsibilities

• Lead and execute the Japan regulatory strategy in alignment with regional and global objectives

• Oversee regulatory submissions, approvals, renewals, and post-market activities for medical devices in Japan

• Act as the primary interface with PMDA, MHLW, and other regulatory authorities

• Manage, develop, and mentor a 10+ member Regulatory Affairs team, ensuring high performance and talent development

• Partner cross-functionally with R&D, Quality, Clinical, Manufacturing, Sales, and Marketing to support product lifecycle management

• Provide strategic regulatory input for new product introductions, line extensions, and labeling changes

• Ensure ongoing compliance with Japanese regulatory requirements, including QMS, vigilance, and post-market surveillance

• Represent Japan Regulatory Affairs in regional and global regulatory forums, contributing to global regulatory strategy

• Monitor regulatory changes and proactively assess business impact

• Support audits, inspections, and internal compliance initiatives

Qualifications & Experience

• Extensive Regulatory Affairs experience within the medical device industry, with deep expertise in Japan regulations

• Proven experience leading and managing mid-to-large regulatory teams (10+ members)

• Strong working knowledge of PMDA/MHLW processes, including Shonin, Ninsho, and Todokede

• Experience operating in a global organization

• Strategic mindset with the ability to balance compliance and business objectives

• Excellent communication and stakeholder management skills