Sr. Director, RAQA - Japan

Job description

Primary Function of Position The Senior Director, Japan RAQA, is responsible for leading and overseeing all aspects of Regulatory Affairs, Quality Assurance and Safety Control within the Japanese market. This critical leadership role ensures regulatory compliance, maintains the highest quality standards, and prioritizes product safety while fostering a collaborative and high-performing team.

Roles and Responsibilities Regulatory Affairs

Develop and implement comprehensive regulatory strategies for all products, including new product introduction and lifecycle management. Ensure timely and accurate submission of all regulatory filings to relevant authorities (e.g., PMDA, MHLW). Proactively monitor and interpret evolving regulatory requirements to identify and mitigate potential compliance risks. Effectively represent the company before regulatory agencies during inspections and audits.

Quality Assurance

Oversee the implementation and maintenance of a robust and compliant Quality Management System (QMS) aligned with ISO 13485 and other relevant standards. Lead internal and external audits to assess QMS effectiveness, identify areas for improvement, and drive continuous quality enhancement. Manage CAPA processes effectively to address quality issues and prevent recurrence.

Safety Control

Establish and maintain a comprehensive safety management system, including robust risk management, adverse event reporting, and field action management processes. Conduct regular safety reviews and risk assessments to proactively identify and mitigate potential hazards. Oversee the investigation and reporting of adverse events and product complaints. Collaborate closely with Clinical Affairs and other departments to address product safety issues.

Leadership & Management

Recruit, hire, and develop a high-performing team of RA/QA/Safety Control professionals. Provide effective leadership, coaching and mentorship to team members. Ensure a positive, collaborative and productive working environment with optimal resource allocation and budget management. Represent Japan RA/QA/SC on the Japan Leadership Team (JLT). Assume responsibility as Sokatsu-sekininsha (General Manager) under the J-PMD Act.

Strategic Direction

Manage the new product introduction roadmap in alignment with regulatory and business objectives. Collaborate effectively with internal and external stakeholders, including ISJ, APAC RAQA, Global RAQA, Marketing, SCM, R&D and manufacturing teams. Develop and maintain strong relationships with government agencies, including MHLW and PMDA. Stay informed about industry trends and emerging regulations to ensure the company's continued compliance and competitiveness.

Qualifications

Required Skills and Experience

Master's degree or higher in a relevant scientific discipline (e.g., Engineering, Life Sciences) preferred. 15+ years of experience in the medical device industry with a strong emphasis on Regulatory Affairs, Quality Assurance and Safety Control. Proven experience and educational background to assume the responsibility of Sokatsu-sekininsha under the J-PMD Act. Direct experience interacting with and navigating the PMDA/MHLW regulatory landscape.

Leadership & Management

Proven leadership and management skills with a successful track record of building, leading, and motivating high-performing teams.

Technical Expertise

In-depth knowledge of ISO 13485, FDA regulations and other relevant global and Japanese standards. Strong understanding of medical device design, manufacturing and quality assurance principles. Experience in planning and implementing clinical programs.

Skills

Excellent communication, interpersonal and presentation skills. Strong communication skills; writes clearly and concisely and expresses ideas fluently. Proven experience developing teams, coaching and mentoring. Experience building collaborative relationships. Strong analytical, problem-solving and decision-making abilities. Proficiency in regulatory submission software and quality management systems. Ability to work effectively in a fast-paced, dynamic and cross-functional environment.

Ability to work under pressure and meet deadlines. Fluency in English and Japanese (written and spoken).