RA Specialist I Job

BS Biology RA Specialist Job Opening at Bio-Rad – Apply Online

We are seeking a motivated individual to provide regulatory support for IVD products within multiple product groups in clinical diagnostics. The role involves assembling low to medium complexity regulatory submissions to facilitate worldwide product registration, maintaining IVDR Technical files, monitoring change requests, and implementing process improvements to SOPs as part of the full transition to IVDR. Daily tasks include interfacing with desktop publishers, technical writers, and regulatory specialists, as well as collaborating with Marketing, R & D, QA, Planning, and Manufacturing teams.

About Company:

Welcome to Bio-Rad! We have been dedicated to advancing the discovery process and transforming the fields of science and healthcare for 70 years. As one of the top five life science companies globally, we specialize in developing, manufacturing, and marketing high-quality research and clinical diagnostic products to help people live longer, healthier lives. At Bio-Rad, you’ll experience a collaborative environment that spans the globe, fostering leadership support to grow your career and empower you to create impactful change.

How You’ll Make An Impact:

  • Strong prioritization skills, flexibility, and ability to handle multiple projects simultaneously while meeting deadlines as RA Specialist I
  • Effective communication with employees across various departments
  • Highly organized and detail-oriented with good time management
  • Technical aptitude for understanding IVD product features
  • Proficiency in databases and electronic systems

What You Bring as RA Specialist I Job:

  • Education: BS in Biology or other scientific field
  • Work Experience: 0-2 years in IVD regulatory affairs as RA Specialist I
  • Proficient use of MS Office applications (e.g., Excel, Word, PowerPoint, Teams)
  • Preferably, laboratory research experience in an IVD medical device regulated environment
  • Understanding of scientific reports, risk management, and Quality Systems

Compensation: The estimated hourly range for this position is $35.28 to $44.00 per hour. Actual compensation will be provided in writing at the time of offer based on factors such as geographic location, experience, knowledge, and skills. As a temporary associate, your employment will be managed through our approved agency provider.

EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer. We encourage candidates of all backgrounds to apply.

Agency Non-Solicitation: Bio-Rad does not accept unsolicited agency resumes. Please do not submit resumes unless authorized to do so.

APPLY ONLINE HERE

Keywords: RA Specialist, Bio-Rad, Temporary, Regulatory Affairs, Jobs, IVD, Clinical Diagnostics. BS Biology RA Specialist Job Opening at Bio-Rad – Apply Online.

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