Japanese Bilingual FDA Research and Regulatory Consultant (Torrance)

Japanese
Bilingual FDA Research & Regulatory ConsultantEmployment
Type: Full-time /
Part-timeWork Location: Torrance, CA (In-Person)Work
Schedules: Monday to
Friday, 9:00 AM – 6:00 PM (Hours are negotiable; flexible schedule options
available)Job OverviewA 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 & SubmissionsExtract
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 & ConsultingInitiate
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 CommunicationPlan
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.QualificationsNative
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.