RA Director

As a trusted partner, our Public Health mission is to make food systems safer, healthier and more sustainable. Throughout our global network in 27 countries, we offer to our customers a wide range of testing and innovative solutions dedicated to preventing health risks related to food, environment and consumer goods. External growth has been a key pillar of our history with more than 40 acquisitions completed in the last 10 years.

If you want to contribute to an inspiring long-term purpose, to be part of a fast growing company on a high-value market with significant build-up opportunities, and to grow in an entrepreneurial and warm environment, join us!

■Position Overview
This role is responsible for leading regulatory strategy in the Japan market while acting as a hands-on, playing manager who actively drives regulatory submissions, notifications, and interactions with regulatory authorities to accelerate product launches.
Beyond strategy development, this position is deeply involved in regulatory execution and direct engagement with PMDA and the Ministry of Health, Labour and Welfare (MHLW), personally driving approvals and making a direct impact on business performance.

■Key Responsibilities

Regulatory Strategy and Execution (Hands-on Leadership)
・ Develop and execute regulatory strategies for the Japan market
・ Actively engage in submission and notification processes, driving preparation, review, and filing
・ Personally lead complex or critical projects and drive approval achievement
・ Provide regulatory decision-making across the entire product lifecycle

Regulatory Authority Engagement (Direct Engagement)

・ Lead strategic negotiations with PMDA and MHLW
・ Drive review responses, including assessment of queries and development/execution of response strategies
・ Personally lead regulatory meetings and consultations as needed

Business Partnership
・ Provide regulatory input into market access and reimbursement strategies
・ Collaborate with Medical and Commercial functions to maximize product value
・ Partner with global teams to adapt and implement regulatory strategies tailored to the Japan market

Regulatory Compliance
・ Ensure compliance with PMD Act and all applicable regulations
・ Optimize and enhance submission processes and operational workflows

People Management
・ Lead the regulatory organization, including strategy and overall team management
・ Drive hiring, development, performance management, and succession planning
・ Support team members’ execution while also contributing as a hands-on individual contributor
・ Build a high-performing team culture balancing expertise and speed
・ Strengthen collaboration across cross-functional and global teams

■Qualifications

【Required】
・ Regulatory affairs experience in IVD and/or medical devices
・ In-depth knowledge of the PMD Act and relevant regulations
・ Proven hands-on experience leading submissions and notifications
・ Direct experience interacting with PMDA and MHLW
・ People management experience
・ Native-level Japanese and business conversational level English

【Preferred】
Experience working in a global matrix organization

■Why this role
A highly empowered role that combines strategic leadership and hands-on execution
Direct impact of your decisions and actions on approval timelines and business outcomes
Opportunity to build strong relationships with regulatory authorities
Lead decision-making for the Japan market in collaboration with global team.