IVD Regulatory Specialist I — Fast-Paced, Detail-Driven

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

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.