Associate Director, Regulatory Affairs and Quality

Responsibilities

• Lead and manage the day-to-day activities of the Japan Quality Assurance (QA) and Regulatory Affairs (RA) teams.
• Develop and execute regulatory strategies for new and existing products to ensure optimum market access in Japan.
• Provide strategic regulatory expertise as a member of the Japan leadership team and the Global Regulatory Affairs Leadership team.
• Coordinate and monitor the development and implementation of the Japan quality system, including Audit and CAPA systems.
• Manage regulatory deliverables throughout the entire product lifecycle.
• Lead regulatory policy shaping in partnership with Government Affairs.
• Coordinate and lead regulatory and certification inspections and manage all communications with regulatory agencies.
• Act as an in-house consultant on complex quality issues and provide technical guidance during internal audits.
• Ensure compliance with local vigilance reporting requirements and interact with Global Patient Safety teams.

Requirements

• Bachelor's degree in a scientific discipline, business, or industrial engineering.
• Minimum of 12 years of experience in the medical device industry.
• Minimum of 8 years of experience in regulatory affairs responsibility within pharmaceuticals and/or medical devices.
• Minimum of 8 years of GMP/QSR quality management experience.
• Proven experience with PMDA submissions.
• Minimum of 5 years of experience directly managing and developing teams.
• Extensive knowledge of GMP/GQP medical device regulations and Japanese/international standards.
• Ability to travel internationally approximately 20%.

Preferred Qualifications

• Advanced degree in a relevant scientific or business field.
• Experience within the pharmaceutical industry.

About the Company

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care, and we are now expanding our commitment to transforming vital organ therapies through digital solutions and advanced services.