Regulatory Specialist

RA Specialist I

Hercules, California
12 month assignment (potential to extend)
Pay Rate: $35-40/hour

Essential Onsite-M-F 8:00 to 4:30

Our leading biotechnology client is looking for an RA Specialist with experience in the IVD medical device industry to join their innovative team in Hercules, CA!

Duties:

Provide regulatory support for IVD products with multiple product groups within clinical diagnostics.
Work with regulatory database to post Instructions for use.
Assembles low complexity regulatory submissions to support worldwide product registration.
Basic analytical, communication, problem solving, critical thinking, and database management to meet daily job responsibilities.
Interface daily with desktop publisher, technical writers and Regulatory Affairs Specialists. Work collaboratively with Marketing, R&D, QA, Planning, and Manufacturing teams.

How You'll Make An Impact:
Strong prioritization skills, flexibility and ability to handle multiple projects simultaneously while meeting deadlines
Ability to communicate effectively with employees across multiple departments
Highly organized and detail-oriented. Good time management.
Technical aptitude for understanding IVD product features

What You Bring:
Education: BS in Biology with emphasis in biology.
Work Experience: 0-2 years experience in IVD regulatory affairs.
Proficient use of MS Office applications (e.g., Excel, Word, PowerPoint, Teams)
Laboratory research experience in an IVD medical device regulated environment.

by Jobble

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