RA Specialist I - Temporary

Tri-Valley Career Center; Hercules (CA); On-site; USD 44,083 - 48,216; Full time

Job summary

Bio-Rad is seeking a Regulatory Support Specialist for IVD products in Hercules, CA. You will assemble low to medium complexity regulatory submissions to support worldwide product registrations and collaborate daily with R&D, QA, planning and manufacturing teams.

Ideal candidates have a BS in Biology or a related field and 6 months to 2 years in IVD regulatory affairs, plus proficiency with MS Office and strong organizational skills. A laboratory background is preferred.

Qualifications

• BS in Biology or related field.
• 6–24 months experience in IVD regulatory affairs.
• Proficient with MS Office (Excel/Word/PowerPoint).
• Experience with regulatory submissions and risk management in a regulated environment.

Responsibilities

• Provide regulatory support for IVD products across product groups.
• Assemble regulatory submissions for worldwide product registrations (low to medium complexity).
• Coordinate with R&D, QA, Planning and Manufacturing teams.
• Interface with technical writers and regulatory specialists.

Skills

Prioritization

Communication

Time management

Technical aptitude

Databases / EHR systems

Education

BS in Biology or related field

Tools

MS Office

Job description

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. 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.

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

Compensation

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. As a temporary associate, your employment will be managed directly through our approved agency provider.

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.