Japanese Bilingual FDA Researcher

Japanese Bilingual FDA Researcher

Work Location : Torrance, CA

Hours : 9am-6pm

Overview :

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.

Essential Duties and Responsibilities include but not are limited to :

• 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.

Qualifications

The base pay range above represents the low and high end of the base compensation range we reasonably expect to pay for this position. Actual base compensation will vary and may be above or below the range based on various factors including, but not limited to, geographic location, actual experience, and job performance. This job posting is not a promise of any specific pay for any specific employee.

The range listed is just one component of the total compensation package for our employees. Based on the details of your position, we provide a variety of benefits to our employees, including medical, dental, and vision plans, pre-tax savings plans, pre-tax parking and commuter plans, supplemental health and welfare plans, a retirement savings plan, an employee assistance program, pet insurance, and paid holidays. Other rewards may include short-term incentives and paid time off.

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About Staffmark

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