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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.
E ssential 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.
Q ualifications
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.
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.
About Us
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 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.
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.