Position Title
Regulatory Affairs Specialist
Company
Confidential International Healthcare Manufacturer
Employment Type
Full-time
Location
Japan
About the Company
International healthcare manufacturer with a broad medical device portfolio
Products supplied to healthcare institutions across multiple therapeutic and clinical areas
Business operations in Japan include commercial, manufacturing, logistics, and sterilization functions
Product portfolio includes surgical products, nonwoven medical consumables, PPE, respiratory care products, and catheter-related devices
Role Overview
Support regulatory affairs activities for medical devices in the Japan market
Manage product submissions, regulatory documentation, authority communications, and QMS-related activities
Collaborate with both local and global stakeholders to ensure regulatory compliance and smooth product approvals
Key Responsibilities
Prepare and manage regulatory submissions for medical devices, including new applications, change applications, and notifications
Compile, review, and submit documentation required for approvals and certifications
Respond to inquiries and communications from regulatory authorities
Support QMS conformity assessment activities, including initial and periodic assessments
Manage regulatory documentation and related administrative activities
Coordinate with internal teams and overseas manufacturers on submission requirements
Support cross-functional regulatory projects and business initiatives as needed
Required Qualifications
Experience in medical device regulatory affairs within Japan
Hands-on experience preparing and managing regulatory submissions through approval or certification stages
Ability to independently manage submissions using documentation from overseas manufacturers
Intermediate English communication skills for collaboration with global stakeholders
Strong PC skills including Microsoft Word, Excel, PowerPoint, and Outlook
Strong attention to detail and documentation management capabilities
Preferred Qualifications
Business-level English communication skills, including meeting participation and document translation
Experience working with industry associations or external regulatory organizations
Experience handling change control and change assessment activities
Preferred Candidate Profile
Able to develop and propose regulatory strategies aligned with business objectives
Strong communication and stakeholder coordination skills
Comfortable working cross-functionally in an international environment
Proactive and detail-oriented working style
Capable of managing multiple projects and deadlines simultaneously