Japanese Bilingual FDA Researcher

Staffmark Group•Torrance, CA

78d•$45,000 - $70,000•Onsite

About The Position

A consulting firm specialized in regulatory compliance solutions is looking for a Japanese Bilingual Researcher to join the team. The Researcher is responsible for managing regulatory strategy and submission projects by conducting research and liaising with agencies. The ideal candidate has the science background in Education (i.e. biology, chemical, bioengineering) and is interested in consulting and marketing business.

Requirements

Bachelor's degree in science (i.e. biology, chemical, bioengineering).
Bilingual Japanese and English (reading/ writing/ speaking)
1+ year of work experience preferred but not mandatory

Responsibilities

Perform project management of the regulatory process for Japanese companies with medical device, pharmaceutical and OTC drugs, and food and supplemental products.
Support clients with product deployment in the U.S. market by serving as a point of contact point to the regulatory authorities.
Plan and schedule project milestones with the manager and client counterparts.
Initiate and conduct research on applicable FDA, EPA and other regulations to assigned projects and compile reports.
Extract information through literature searches to develop understanding of requirements and support regulatory documents (510(k), De Novo, Pre-submission, Annual Report, PMA, IDE, BLA, DMFs).
Prepare and develop a set of documents to submit to government authorities.
Assist senior consultants in creating product launch strategies, development roadmaps, and commercialization master plans for complex accounts.
Attend meetings with client companies and regulatory agents, and prepare and translate meeting minutes as needed.
Other duties assigned by Management.