Japanese Bilingual FDA Research and Regulatory Consultant

Japanese Bilingual FDA Research & Regulatory Consultant

A consulting firm is seeking a dedicated and Japanese bilingual FDA Research Consultant to join their team. This role serves as a bridge between US regulatory bodies and Japanese clients. You will conduct in-depth research on US regulations (FDA, EPA) regarding medical devices and pharmaceuticals in English, and analyze this information to provide strategic consulting and professional reports in Japanese. The ideal candidate is a proactive professional with a background in science or engineering who understands Japanese business etiquette and can communicate effectively with major Japanese corporations, and American government agencies and universities.

This is a great opportunity if you are interested in consulting and marketing business.

Essential duties and responsibilities include but are not limited to:

• Regulatory Affairs & Submissions:
  Extract information through literature searches and technical data analysis to support and prepare critical regulatory documents, including 510(k), De Novo, Pre-submission, Annual Reports, PMA, IDE, BLA, and DMFs. Serve as the primary point of contact for regulatory authorities (FDA, EPA, etc.) to support client product deployment in the US market. Prepare, develop, and organize complete sets of documents for submission to government authorities, ensuring strict adherence to compliance standards.
• Research, Strategy & Consulting:
  Initiate and conduct comprehensive research on applicable US regulations (FDA, EPA) using English resources, covering medical devices, pharmaceuticals, and related industries. Analyze regulatory data to create high-quality consulting reports and presentation materials in professional Japanese, tailored for client decision-making. Assist senior consultants in developing product launch strategies, development roadmaps, and commercialization master plans for complex accounts. Perform local field research and business investigations to support client market entry and competitor analysis.
• Project Management & Client Communication:
  Plan and schedule project milestones, coordinating closely with the Manager and client counterparts to ensure timely delivery. Act as a cultural and communication bridge between the US and Japan, utilizing strong bilingual skills to navigate business differences and facilitate smooth operations. Attend meetings with client companies and regulatory agents; prepare and translate meeting minutes and lead reporting sessions to clearly communicate complex regulatory concepts.
  
  Perform other duties as assigned by Management to support the team's success.

Qualifications:

• Native or professional bilingual fluency in both English and Japanese (reading, writing, and speaking).
• Bachelor's degree in a science-related field (e.g., Biology, Chemistry, Biochemistry, Engineering, Physics, Medical, Pharmaceutical).
• Knowledge or interests in FDA and other regulatory compliance frameworks.
• Deep understanding of Japanese business customs and the ability to maintain professional correspondence with high-level stakeholders (major companies, government, academia).
• 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 not required). Previous business experience, preferably within the medical, pharmaceutical, or food industries is a plus.

About Us:

At Staffmark, we connect hardworking people with great companies, creating opportunities that make a lasting impact. Staffmark is an equal opportunity employer. All applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Staffmark offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries.

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