Compliance Specialist 2

The Compliance Specialist 2 at Intuitive is a pivotal role within the company's Quality & Regulatory team, focusing on ensuring compliance with post-marketing safety regulations and quality management systems. This position is based in Tokyo, Japan, and involves close collaboration with both local and international teams to uphold the company's commitment to safety and quality in medical devices.

Key responsibilities include preparing and implementing Good Vigilance Practices (GVP) in compliance with Japanese Pharmaceutical Affairs Law (PAL), collecting and reviewing post-marketing safety information from both local and overseas sources, and managing complaint handling processes, including the preparation of customer communications. The role also involves supporting quality management activities in cooperation with the Quality Assurance (QA) team, maintaining Standard Operating Procedures (SOPs) for post-marketing filings, complaint handling, and quality management, and working directly with regulatory agencies on safety and quality issues.

Candidates should possess 3-5 years of experience working directly with the Ministry of Health, Labour and Welfare (MHLW) and other governmental agencies on post-marketing and/or quality assurance matters. A strong understanding of Japanese and international regulations regarding medical device safety and quality management is essential. Excellent verbal and written communication skills are required, with the ability to translate technical documentation into effective regulatory documents. The role demands a friendly, positive attitude that fosters cooperation and careful documentation practices.

While specific compensation details are not provided, Intuitive offers market-competitive compensation packages, including base pay, incentives, benefits, and equity. The company emphasizes a supportive work environment with opportunities for professional growth and development.

Intuitive is a pioneer and market leader in robotic-assisted surgery, committed to advancing minimally invasive care. The company fosters an inclusive and diverse team, encouraging innovation and collaboration. Employees are empowered to contribute to meaningful work that impacts healthcare globally.