Job Description

Regulatory Affairs Specialist I -

Hybrid after 30 days M and Tuesdays on site, the third day candidate’s choice. 8:00 to 4:30

Experience in IVD medical device industry. is MANDATORY

Duration - 1 year

Hourly Pay - Depending on experience - Up to max $40 / Hour

First 30 days 100% onsite work and then Hybrid - 3 days onsite every week - 8 AM to 4.30 PM at Hercules, CA

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. IVDR Technical file maintenance and monitoring of change requests. Process improvements for SOPs related to full transition to 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 Marketing, 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: 3-5 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

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