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Job Information
Job title

Regulatory Affairs Specialist

Company Haemometics
Wage Not specified
Location United States, Massachusetts, Braintree
Employment type Full Time
Education Not Specified
Year Experience 4 - 5 Years of Practical Experience
Travel None
Published on 6/9/2005
Description
Bachelors Degree in a technical discipline required. 3-5 years experience in regulatory affairs within the medical device industry, including writing premarket submissions. Must have experience in FDA submissions and CE technical file requirements.

Responsible for compiling and writing submission documents for product approvals for the US FDA and Health Canada. These documents include 501(k) Premarket Notifications, Investigational Device Exemption applications, Technical Files, Canadian Medical Device License applications and amendments, and appropriate follow-up responses and reports. This position works with program teams in identifying regulatory requirements early in the new product development process. Participate as a member of a product development team to provide regulatory support to the project.df-tc

Experience/Skills
See Above

Other desired skills:
Regulatory Affairs Specialist
This job has expired.