【東京｜医療機器｜薬事】 薬事ディレクター/RA Director

OBJECTIVES/PURPOSE OF JOB
The Senior Regulatory Affairs Manager is responsible for leading regulatory strategy and execution in Japan for a portfolio of medical devices and healthcare products.
This role serves as the primary interface with PMDA, MHLW, and relevant authorities, driving successful product registrations, lifecycle management, and compliance. The position plays a critical role in integrating Japan regulatory requirements into global development programs, while building a high-performing regulatory team and
partnering closely with Quality and Commercial functions to ensure business success.

Key Responsibilities
1. Japan Regulatory Strategy & PMDA Submissions (Core Focus)
Lead development and execution of Japan regulatory strategies across the full product lifecycle
Own and drive end-to-end PMDA submissions, including:
o Class II,IV medical device approvals and certifications
o Healthcare product registrations and variations, as applicable
o Lifecycle submissions (partial changes, renewals, updates)
Develop and execute PMDA consultation strategies, including pre-submission interactions, scientific advice, and issue resolution
Ensure submissions are high-quality, compliant, and aligned with business timelines and launch objectives

2. Clinical & Regulatory Integration
Provide regulatory leadership for clinical evidence requirements for Japan, including:
o Evaluation of clinical data needs for device approvals
o Bridging strategies using global data where applicable
o Input into clinical/regulatory pathways for new and modified devices
Partner with global Regulatory, Clinical, and R&D teams to ensure:
o Early incorporation of Japan requirements into development programs
o Alignment of Japan strategy with global submissions

3. Health Authority Leadership
Serve as the primary company representative to PMDA, MHLW, and local authorities
Lead regulatory consultations, negotiations, and formal interactions
Proactively manage regulatory risks and drive issue resolution with authorities
Build and maintain strong, credible relationships to facilitate efficient approvals

4. Cross-Functional Partnership (Critical Success Factor)
Partner closely with Quality to ensure:
o Alignment on QMS requirements, inspections, and compliance
o Successful execution of QMS submissions and foreign manufacturing registration
Partner with Commercial/Marketing to:
o Enable compliant and competitive product launches
o Review and approve promotional materials and claims
o Ensure labeling supports both regulatory and market needs
Collaborate with Supply Chain, Manufacturing, and Technical teams to ensure alignment on regulatory requirements for product changes and launches

5. Labeling, Promotion & Compliance
Lead regulatory review and approval of:
o Labeling, IFUs, packaging, and product claims
o Promotional and advertising materials for compliance 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 (ISO, IEC, etc.)
Provide strategic insights to internal stakeholders to guide product development and lifecycle planning
Participate in industry associations and regulatory forums to stay ahead of policy changes

7. People Leadership & Team Development
Build, lead, and develop a high-performing Regulatory Affairs team in Japan
Provide coaching, mentoring, and structured development plans
Drive a culture of accountability, speed, collaboration, and continuous improvement
Ensure strong succession planning and capability building

8. Business & Operational Leadership
Lead regulatory project management for Japan submissions and approvals
Manage the Japan RA budget and resource planning
Support new product introductions and business development from a regulatory feasibility perspective

SUPERVISE DIRECT REPORTS: Yes

SCOPE OF POSITION
Recruitment, education, and team management of RA team staffs
Project Management for regulatory submissions
Responsible for business license maintenance
Manages RA budget.

KEY RELATIONSHIPS
Internal
Global Regulatory Affairs (core partner for global program alignment)
Quality Assurance and Compliance
Clinical, R&D, and Medical Affairs
Commercial / Marketing / Market Access
Supply Chain and Manufacturing
External
PMDA, MHLW, and local authorities
Industry associations (e.g., device and pharma groups)
Regulatory consultants and external partners

Employee Benefits:
Employment Type: Full time employee
Office Location: Central Tokyo, Japan
Working Model: Hybrid, 2-3 days in office with flex time.
Interviews: 2-3
Budget: Up to 18 Mil (base+bonus)
Welfare and Insurances: Covered

QUALIFICATIONS/ TRAINING (e.g. professional qualifications, on-the-job training,
education)
Bachelor’s degree in a scientific or technical field (e.g., engineering, life sciences); advanced degree preferred
Pharmacist license is a plus

Experience
10+ years of Regulatory Affairs experience in medical devices and/or combination products
Strong track record of PMDA submissions and approvals for medical devices (Class II?IV)
Experience with quasi-drug regulatory pathways preferred
Demonstrated experience in Health Authority interactions and regulatory negotiations in Japan
Experience supporting clinical/regulatory strategy for device approvals
5+ years of people leadership experience, including team development
Experience working in global, matrixed organizations

Skills & Competencies
Deep expertise in:
o Japan medical device regulations and PMDA processes
o QMS requirements and regulatory compliance in Japan
o Labeling and promotional review requirements
Strong ability to:
o Lead complex submissions and navigate regulatory ambiguity
o Influence cross-functional and global stakeholders
o Translate global strategy into Japan-specific execution
Excellent:
o Project management and problem-solving skills