Customer Advocacy Specialist

• Establish and maintain the Good Vigilance Practice (GVP) process for the Japanese market
• Gather, analyze, and report on adverse events related to medical devices
• Prepare and submit regulatory reports to relevant agencies
• Ensure compliance with medical device regulations and guidelines
• Collaborate with cross-functional teams to drive continuous improvement

• Minimum of 3 years of experience in complaint handling and vigilance reporting in the medical device or IVD industry
• Proven ability to perform routine tasks with accuracy and attention to detail
• Excellent problem-solving and analytical skills
• Effective communication skills in English and Japanese (written and verbal)
• Ability to read, interpret, and write reports and correspondence
• Experience working within a regulated environment (e.g., ISO 13485)
• Strong understanding of medical device regulations in Japan
• Adaptability and flexibility to changing priorities
• Bachelor's degree in a relevant scientific or engineering field

Experience with global regulatory reporting systems is a plus

• A full and comprehensive benefits program
• Growth opportunities on a global scale
• Access to career development through in-house learning programs and/or qualified tuition reimbursement
• An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve
• Health insurance
• Employee pension insurance
• Employment insurance
• 11% bonus