[Remote] Regulatory Affairs Expert ~ Medical Device

Company Overview A global regulatory and compliance solutions provider, primarily focused on the life sciences and healthcare industries. The company offers a broad range of services, including regulatory affairs, product registration, market access, and other services that help pharmaceutical, biotechnology, medical device, and consumer health companies navigate complex regulatory frameworks and ensure compliance with local and international regulations. Job Description Lead the development and implementation of regulatory strategies for Class III and IV medical devices and IVDs. Specialized in identifying opportunities, delivering effective regulatory solutions, and ensuring timely project execution 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.