Japanese Bilingual FDA Research and Regulatory Consultant

Posted 17 days ago

staffmarkIndustry (CA)

Regulatory Affairs Specialists Research and Development in Biotechnology (except Nanobiotechnology)

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About the role

Japanese Bilingual FDA Research & Regulatory Consultant Employment

Type: Full-time /Part-time

Work Location: Torrance, CA (In-Person)

Work Schedules: Monday toFriday, 9:00 AM – 6:00 PM (Hours are negotiable; flexible schedule optionsavailable)

Job Overview:

A consulting firmis seeking a dedicated and Japanese bilingual FDA Research Consultant to jointheir 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 thisinformation to provide strategic consulting and professional reports inJapanese.
The idealcandidate is a proactive professional with a background in science orengineering (i.e. biology, chemical, bioengineering) who understands Japanese businessetiquette and can communicate effectively with major Japanese corporations, and
American government agencies and universities. This is a great opportunity ifyou are interested in interested in consulting and marketing business.
Essential Duties and Responsibilities include but notare limited to:1. Regulatory
Affairs & Submissions
Extractinformation through literature searches and technical data analysis tosupport and prepare critical regulatory documents, including 510(k), DeNovo, Pre-submission, Annual Reports, PMA, IDE, BLA, and DMFs.
Serveas 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 togovernment authorities, ensuring strict adherence to compliance standards.2. Research, Strategy & Consulting
Initiateand conduct comprehensive research on applicable US regulations (FDA, EPA)using English resources, covering medical devices, pharmaceuticals, andrelated industries.
Analyzeregulatory data to create high-quality consulting reports and presentationmaterials in professional Japanese, tailored for client decision-making.
Assistsenior consultants in developing product launch strategies, developmentroadmaps, and commercialization master plans for complex accounts.
Performlocal field research and business investigations to support client marketentry and competitor analysis.3. Project
Management & Client Communication
Planand schedule project milestones, coordinating closely with the Manager andclient counterparts to ensure timely delivery.

Act asa cultural and communication bridge between the US and Japan, utilizingstrong bilingual skills to navigate business differences and facilitatesmooth operations. Attendmeetings with client companies and regulatory agents; prepare andtranslate meeting minutes and lead reporting sessions to clearlycommunicate complex regulatory concepts. Performother duties as assigned by Management to support the team's success.

Qualifications: Nativeor professional bilingual fluency in both English and Japanese (reading, writing, and speaking).Bachelor'sdegree in a science-related field (e.g., Biology, Chemistry, Biochemistry, Engineering, Physics, Medical, Pharmaceutical). Knowledgeor interests in FDA and other regulatory compliance frameworks. Deepunderstanding of Japanese business customs and the ability to maintainprofessional correspondence with high-level stakeholders (major companies, government, academia).Strongproficiency in Microsoft Office Suite (Word, Excel, PowerPoint).Professionaland positive mindset. Adaptable and willing to take on various tasks asthe company grows. TeamPlayer who thrives in a supportive, family-like office atmosphere. Master'sdegree or PhD in a scientific discipline (preferred not required).Previousbusiness experience, preferably within the medical, pharmaceutical, orfood 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.

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