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OCRA Webinar - What is Regulatory Affairs? How can I break into it?
Wednesday 20 February 2019, 12:00pm - 01:30pm
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What is Regulatory Affairs?  How can I break into it?

Does not require OCRA membership - Registration Required

Starting a new career?  Have you heard of Regulatory Affairs?
Looking for a change in your career? 
Ever wonder how people become a Regulatory Specialist? 

Come and join us.
Come and learn what a Regulatory Affairs
Specialist does.
How did they get where they are? 

Webinar Participation Details will be
emailed prior to the webinar 

Speaker:Webinar Photo

Eri Hirumi, OCRA Board Member 

Armed with a bachelor’s degree in Biochemistry and Molecular Biology, Eri started as a Development Chemist for a very small electrophoresis product line requiring a broad spectrum of skills within the complete product life cycle. This position highlighted the key importance of managing documentation. A growing knowledge of product labeling sparked her interest in other parts of regulatory, such as chemical safety and requirements for Material Safety Data Sheets and a wide variety of regulations.

Working on the labeling requirements led to an opportunity to lead the Technical Publications group in Brea.  This in turn required a detailed knowledge of world-wide IVD requirements and the interplay with different standards. This helped Eri shift her career into Regulatory Affairs. Recently Eri has continued her professional development by working, as an auditor for TÜV SÜD. This has helped cement the knowledge for Quality Management Systems for the European requirements.

Eri continues to expand her knowledge on global Regulatory and Quality Management System requirements. To ensure high quality and innovative compliance during the complete medical device product life cycle, continual education with regulatory and industry leaders is critical. As such, Eri is dedicated in providing opportunities for all stakeholders to interact and exchange technical knowledge, practical applications and creative problem solving.

Program Description:

The following topics will be discussed:
            What is a Regulatory Affairs (RA) in general?
            What does a RA specialist do?
            How is RA different from QA (Quality Assurance)?
            What is a typical day?
            What are the sub specialties with this job?
            What skill sets are important?
            Some tips on how to start in the career?
            Some tips on how to transition into a regulatory affairs career.


Be sure to join us!

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