[Remote] Regulatory Affairs Expert ~ Medical Device

• Plan and implement regulatory strategies for Class III/IV medical devices, IVDs, and SaMDs.
  
• Manage end-to-end product registration with internal teams, consultants, and health authorities.
  
• Deliver regulatory projects and solutions across regional client portfolios.
  
• Support proposal development and project evaluations (e.g., RFPs).
  
• Serve as Japan regulatory SME for medical devices; IVD/SaMD expertise preferred.
  
• Scale operations to support multiple projects and clients efficiently.
  
• Train internal teams, especially India-based staff, on document preparation in English.
  
• Set up robust translation processes for Japan regulatory submissions.
  
• Review and submit regulatory documents; follow up with Japanese authorities until approval.
  
• Monitor Japan's regulatory changes and support business growth initiatives.
  
  

Requirements

• Proficiency (speaking and writing) in Language: Good command in native-level Japanese and English.
  
• Experience in Medical Device, with experience in a global regulatory affairs role including regulatory strategy, planning and execution for the new devices in the country.
  
• Exposure or experience in QMS & Vigilance is plus point.
  
• Good experience in Class III and Class IV Medical devices. The same for IVDs is desired.
  
• Experience and/or Exposure with SaMD would be an additional advantage.