The Director, Regulatory Affairs role offers the opportunity to lead regulatory strategy and execution in Japan for a portfolio of medical devices and healthcare products. This is a highly visible leadership position responsible for driving successful product approvals, managing relationships with regulatory authorities, and ensuring alignment between local regulatory requirements and global development programmes. The role is ideal for an experienced regulatory professional who enjoys leading complex submissions, building high-performing teams, and partnering across functions to support business growth.
Responsibilities
1. Japan Regulatory Strategy & PMDA Submissions
Lead the development and execution of regulatory strategies in Japan across the full product lifecycle
Own and drive end-to-end PMDA submissions, including:
Class II-IV medical device approvals and certifications
Healthcare product registrations and variations, where applicable
Lifecycle submissions including partial changes, renewals, and updates
Develop and execute PMDA consultation strategies, including pre-submission interactions, scientific advice, and issue resolution
Ensure submissions are compliant, high quality, and aligned with business timelines and launch objectives
2. Clinical & Regulatory Integration
Provide regulatory leadership regarding clinical evidence requirements for Japan, including:
Evaluation of clinical data requirements for device approvals
Bridging strategies utilising global clinical data where appropriate
Input into clinical and regulatory pathways for new and modified devices
Partner with Global Regulatory Affairs, Clinical, and R&D teams to ensure:
Early incorporation of Japan regulatory requirements into development programmes
Alignment of Japan strategy with global submissions
3. Health Authority Leadership
Serve as the primary company representative to PMDA, MHLW, and relevant authorities
Lead regulatory consultations, negotiations, and formal interactions
Proactively identify and manage regulatory risks while driving issue resolution
Build and maintain strong relationships with regulatory authorities to facilitate efficient approvals
4. Cross-Functional Partnership
Partner closely with Quality functions to ensure:
Alignment on QMS requirements, inspections, and compliance
Successful execution of QMS submissions and foreign manufacturing registrations
Collaborate with Commercial and Marketing teams to:
Enable compliant and competitive product launches
Review and approve promotional materials and product claims
Ensure labelling supports both regulatory and commercial requirements
Work with Supply Chain, Manufacturing, and Technical teams to ensure compliance for product changes and launches
5. Labelling, Promotion & Compliance
Lead regulatory review and approval of:
Labelling, instructions for use, packaging, and product claims
Promotional and advertising materials in accordance with Japan regulations
Ensure compliant implementation of product changes through robust change control processes
6. Regulatory Intelligence & External Engagement
Monitor and interpret changes in Japan regulatory requirements and global standards, including ISO and IEC standards
Provide strategic regulatory insights to support product development and lifecycle planning
Participate in industry associations and regulatory forums to stay informed of evolving regulations and policies
7. People Leadership & Team Development
Build, lead, and develop a high-performing Regulatory Affairs team
Provide coaching, mentoring, and structured development planning
Promote a culture of accountability, collaboration, speed, and continuous improvement
Support succession planning and long-term capability development
8. Business & Operational Leadership
Lead regulatory project management for Japan submissions and approvals
Manage Regulatory Affairs budget and resource planning
Support new product introductions and business development initiatives from a regulatory feasibility perspective
Oversee maintenance of business licences and regulatory compliance activities
Requirements
Education & Qualifications
Bachelor's degree in a scientific or technical discipline such as Engineering or Life Sciences
Advanced degree preferred
Pharmacist licence advantageous
Experience
10+ years of Regulatory Affairs experience within medical devices and/or combination products
Proven experience leading PMDA submissions and obtaining approvals for Class II-IV medical devices
Experience with quasi-drug regulatory pathways preferred
Demonstrated experience interacting and negotiating with Japanese health authorities
Experience supporting clinical and regulatory strategies for medical device approvals
5+ years of people leadership experience, including team development
Experience working within global matrix organisations
Skills & Competencies
Deep knowledge of:
Japan medical device regulations and PMDA processes
QMS requirements and regulatory compliance in Japan
Labelling and promotional material review requirements
Strong ability to:
Lead complex submissions and navigate regulatory ambiguity
Influence cross-functional and global stakeholders
Translate global strategy into effective local execution
Excellent project management, communication, and problem-solving skills
Benefits
Hybrid working model
Flexible working arrangements
Medical and insurance coverage
About the Company
A company in the global eye health industry, this organisation develops and supplies a broad portfolio of products including contact lenses, lens care solutions, ophthalmic pharmaceuticals, intraocular lenses, and ophthalmic surgical equipment. With a strong commitment to improving vision and eye health throughout all stages of life, the organisation supports patients and healthcare professionals worldwide through innovative and high-quality healthcare solutions.