Japanese Bilingual FDA Research & Regulatory Consultant

Japanese Bilingual FDA Research & Regulatory Consultant

A consulting firm is seeking a dedicated and 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 (i.e. biology, chemical, bioengineering) 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

• Education: Bachelor's degree or higher (4-year university).
• Technical Skills: Intermediate proficiency in Microsoft Office (Word, Excel, PowerPoint).
• Cultural Competency: Deep understanding of Japanese business customs and the ability to maintain professional correspondence with high-level stakeholders (major companies, government, academia).

Personal Attributes

• Professional & Positive: A hard-working individual with a positive attitude.
• Team Player: Someone who thrives in a supportive, family-like office atmosphere.
• Adaptable: Willing to take on various tasks as the company grows.

Preferred:

• Language: Japanese/English Bilingual. Must be able to research and conduct interviews in English. Must have superior Japanese writing skills for creating formal business reports.
• Education: Master's or Doctoral degree in a STEM field (Science, Technology, Engineering, Math).
• Experience: Prior experience working in the medical device or pharmaceutical industry.

Compensation & Benefits

• Salary: Competitive annual salary based on education and experience.
• Bonuses: Annual Year-End Bonus. Monthly Incentive Bonus (paid separately from base salary). Salary Review: Once a year.
• Visa Support: Green Card sponsorship will be considered for exceptional performers after a period of employment.
• Insurance: Medical, Dental, and Vision insurance; Workers' Compensation.
• Retirement: Retirement fund accumulation (401k or similar).
• Time Off: Paid Paid Time Off (PTO), Sick Leave, Paid Holidays.
• Wellness: Health support and training programs.

Work Environment & Flexibility

• Flexibility: Arrangement of working hours in occasions of necessity such as childcare, nursing care, or academic commitments.

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. Staffmark is an E-Verify employer. See our Privacy Notice for Candidates and Employees/Contractors at By applying, you consent to receive AI-generated and non-AI-generated calls, texts, or emails from Staffmark Group, its affiliates, and partners. Frequency varies and message/data rates may apply. Reply STOP to cancel or HELP for help. The base pay range listed reflects what we reasonably expect to offer for this role. Actual pay may vary based on location, experience, and performance. Depending on the position, 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.