Hercules,
RA Specialist I
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.