Job Description

Duration: 12 months

Hybrid after 30 days M and Tuesdays on site, the third day candidate’s choice.

8:00 to 4:30 however we are flexible.

Experience in IVD medical device industry is required

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.
• 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: 0-2 year’s 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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