Japanese Bilingual FDA Research & Regulatory Consultant

Japanese Bilingual FDA Research & Regulatory Consultant Employment Type:

Full-time Work Hours:

09:00 am - 6:00 pm (Flexible arrangements available)

Work Location:

Torrance, CA Job Overview 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 interested in consulting and marketing business. Essential Duties and Responsibilities include but not are limited to: 1. 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. 2. 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. 3. 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. o Must be able to research and conduct interviews in English. o 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:

o Annual Year-End Bonus. o Monthly Incentive Bonus (paid separately from base salary). o

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.