Sr. Director, RAQA - Japan

Company Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

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).

Additional Information

当社は、法令に従い、全ての応募者について、その適性と能力のみを基準として公正に採用選考を行います。

この職位は、業務上のニーズや、採用候補者の経験、知識、技能に応じて、ここに記載されている職務レベルと異なるレベルで採用される場合があります。

報酬は、主に採用された職務レベルと候補者の資格に基づき、適用される法律に従って決定されます。