RA Specialist I - Temporary

About the role

Provide regulatory support for IVD products with multiple product groups with clinical diagnostics. Assembles low to medium complexity regulatory submissions to support worldwide product registration change requests for IVDR. Works collaboratively with R&D, QA, Planning and Manufacturing teams.

Responsibilities

• Assemble low to medium complexity regulatory submissions for product registration change requests under IVDR
• Interface with desktop publisher, technical writers, and regulatory specialists
• Collaborate with R&D, QA, Planning, and Manufacturing teams
• Communicate effectively with employees across multiple departments
• Handle multiple projects simultaneously while meeting deadlines
• Support the development of scientific reports and risk management strategies
• Understand and apply Quality Systems principles

Requirements

• Basic analytical, communication, problem-solving, and critical thinking skills
• Proficient use of MS Office applications (Excel, Word, PowerPoint, Teams)
• Laboratory research experience in an IVD medical device regulated environment
• Understanding of databases and electronic systems

Qualifications

• BS in Biology or other scientific field
• 6 months to 2 years of experience in IVD regulatory affairs

Skills

• Technical aptitude for understanding IVD product features
• Strong prioritization skills
• Flexibility to handle multiple projects simultaneously
• Good time management
• Highly organized and detail-oriented

Benefits

Not specified

Pay

The estimated hourly range for this position is $32.00 to $35.00 per hour at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors.

Schedule

Not specified

Who We Are

For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives.

EEO Statement

Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with physical or mental disabilities, and people of all race, color, sex, sexual orientation, gender identity, religion, national origin and citizenship status are encouraged to apply.