New

Japanese Bilingual FDA Researcher

Staffmark Group
$45,000.00-$70,000.00
paid time off, paid holidays
United States, California, Torrance
May 13, 2025
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 * 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 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. After you have applied, download our Staffmark Group WorkNOW App to receive real-time job offers and apply for additional opportunities. You can download it from the App Store or get it on Google Play. About Staffmark Staffmark is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact your local branch. Staffmark is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment. All employees are directed to familiarize themselves with this policy and to act in accordance with it. All decisions with respect to employment matters and other phases of employer-temporary employee relationships will be in keeping with this policy and in accordance with all applicable laws and regulations.