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Job Information
Job title

Project Manager Regulatory Affairs - Japan

Company Boston Scientific
Wage Not specified
Location United States, California, Fremont
Employment type Full Time
Education Not Specified
Year Experience 3 - 4 Years of Practical Experience
Travel About 25%
Published on 1/7/2005
Description
RESPONSIBILITIES

Manage Japanese regulatory applications for BSC Fremont Site Businesses (Imaging and Neurovascular).
Support Clinical and Regulatory strategies and submissions for Fremont Site Businesses.
Supports highly technical or major business segment product lines, special projects or strategic initiatives of the Fremont Site Businesses.

Responsible for Regulatory Affairs support of Japanese submissions and ongoing regulatory compliance for product development process.

Coordinate communications between BSJ and Fremont Site.
Manage RA staff members that support Japanese regulatory submissions.

Manage MHLW recertification activities, as needed, to support Fremont Site Products.
Implement PAL and MHLW regulations in Fremont Site.
Develops and implements policies and procedures associated with Japanese regulations and submissions.
Provide departmental training on Japanese regulations.
Implement PAL and MHLW regulations in Fremont Site.

QUALIFICATIONS

Bachelor's degree in scientific or technical discipline and 8+ yr regulatory affairs medical industry experience. Prior people management experience preferred.
-Thorough understanding of Japanese regulations
-Must be willing and able to travel up to 25%
-Must speak and write Japanese fluently
-Strong technical understanding of relevant procedures, practices, and associated medical terminology
-Strong knowledge of clinical trial strategy and study design and sponsor reporting requirements
-Thorough knowledge of product development process and design control
-Excellent research and analytical skills
-Ability to manage multiple projects
-Strong leadership, interpersonal and influencing skillsdf-tc

Experience/Skills
See Description Above

Other desired skills:
Project Manager Regulatory Affairs - Japan
This job has expired.