Regulatory Affairs Expert - Medical Device

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January 7

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Morunda | Pharmaceutical | Medical Device Recruiting | Japan (JPAC) Asia (APAC)

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Pharmaceuticals • Healthcare Insurance • Recruitment

Morunda is a recruitment firm specializing in connecting multinational companies within the pharmaceutical and medical device industries with top talent in Japan and Asia-Pacific. With over 75 years of combined experience, Morunda focuses on placing senior-level professionals and aiding in market entry strategies, ensuring that organizations find the right candidates to drive success in the healthcare sector.

11 - 50 employees

Founded 2011

💊 Pharmaceuticals

⚕️ Healthcare Insurance

🎯 Recruiter

📋 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.