Job Description

RA Specialist -

Work Location - Hercules, CA - Hybrid role - 3 days onsite every week 2 days remote

Shift 8 AM to 5 PM

Pay - $40/hour

IVD Experience is mandatory

Provide regulatory support for IVD products with multiple product groups with clinical diagnostics. Assembles low to medium complexity regulatory submissions to support world wide product registration. IVDR Techical file maintenance and monitoring of change requests. Basic analytical, communication, problem solving, and critical thinking skills to meet daily job responsibilities. Interface daily with desktop publisher, technical writers and regulatory 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
• Understanding of databases and electronic systems.

What You Bring:

• Education:BS in Biology or other scientific field
• Work Experience: 6 mo -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 is strongly preferred.
• Understanding of scientific reports, risk management, Quality Systems

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