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

Schedules: Monday to

Friday, 9:00 AM - 6:00 PM (Hours are negotiable; flexible schedule options

available)

Job Overview

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 (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

• 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.

At Staffmark, we connect hardworking people with great companies, creating opportunities that make a lasting impact.

Staffmark is an equal opportunity employer. Allapplicants 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 https://smgroupna.com/privacy-notice-for-candidates-and-employees-contractors. 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.