Japanese Bilingual FDA Research and Regulatory Consultant

Job Description:

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.

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 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.

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.