Japanese Bilingual FDA Research and Regulatory Consultant

Japanese Bilingual FDA Research & Regulatory Consultant

Employment Type:

Full-time / Part-time

Work Location:

Torrance, CA (In-Person)

Work Schedule:

Monday to Friday, 9:00 AM - 6:00 PM (Hours negotiable; flexible schedule options available)

A consulting firm is seeking a dedicated Japanese bilingual FDA Research Consultant to serve as a bridge between US regulatory bodies and Japanese clients. The role involves conducting in-depth research on FDA and EPA regulations for medical devices and pharmaceuticals in English, analyzing the information, and providing strategic consulting and professional reports in Japanese.

• Regulatory Affairs & Submissions:
  Extract information through literature searches and technical data analysis to support critical regulatory documents including 510(k), De Novo, Pre-submission, Annual Reports, PMA, IDE, BLA, and DMFs; act as primary point of contact for regulatory authorities; prepare, develop, and organize complete sets of documents for submission to government authorities.
• Research, Strategy & Consulting:
  Initiate and conduct comprehensive research on applicable US regulations (FDA, EPA), analyze regulatory data to create high-quality consulting reports and presentation materials in professional Japanese, assist senior consultants in developing product launch strategies, development roadmaps, and commercialization master plans, and perform local field research and business investigations to support client market entry and competitor analysis.
• Project Management & Client Communication:
  Plan and schedule project milestones, coordinate closely with the Manager and client counterparts; act as a cultural and communication bridge between the US and Japan using strong bilingual skills; attend meetings with client companies and regulatory agents, prepare and translate meeting minutes and lead reporting sessions; perform other duties as assigned by Management.

• Native or professional bilingual fluency in English and Japanese (reading, writing, speaking).
• Bachelor's degree in a science-related field (e.g., Biology, Chemistry, Biochemistry, Engineering, Physics, Medicine, Pharmacy).
• Knowledge or interests in FDA and other regulatory compliance frameworks.
• Deep understanding of Japanese business customs and ability to maintain professional correspondence with high-level stakeholders.
• Strong proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Professional and positive mindset; adaptable and willing to take on various tasks as the company grows.
• Team player who thrives in a supportive, family-like office atmosphere.
• Master's degree or PhD in a scientific discipline (preferred).
• Previous business experience, preferably within the medical, pharmaceutical, or food industries.

The base pay range reflects what we reasonably expect to offer for this role; actual pay may vary based on location, experience, and performance. Benefits may include medical, dental, and vision coverage; retirement and savings plans; paid holidays and time off; supplemental insurance; and additional wellness or incentive programs.

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