Regulatory Specialist

1 month ago

Hercules, United States Tucker Parker Smith Group (TPS Group) Full time

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.