RA Specialist I - Temporary

Bio-Rad Laboratories • Hercules, CA

1d

About The Position

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 change requests for IVDR. 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 R & D, QA, Planning and Manufacturing teams.

Requirements

• BS in Biology or other scientific field
• 6 mo - 2 years experience in IVD regulatory affairs.
• Proficient use of MS Office applications (e.g., Excel, Word, PowerPoint, Teams)

Nice To Haves

• Laboratory research experience in an IVD medical device regulated environment is strongly preferred.
• Understanding of scientific reports, risk management, Quality Systems
• 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.

Responsibilities

• Assemble low to medium complexity regulatory submissions to support worldwide product registration change requests for IVDR.
• Interface daily with desktop publisher, technical writers and regulatory specialists.
• Work collaboratively with R & D, QA, Planning and Manufacturing teams.

Benefits

• The estimated hourly range for this position is $32.00 to $35.00 per hour at the time of posting.

What This Job Offers

• Career Level: Entry Level