Entry-Level Regulatory Affairs Specialist – IVD Diagnostics

Viltis; South Portland (ME); On-site; USD 55,000 - 85,000; Full time

Job summary

Viltis is seeking a detail-oriented Regulatory Affairs Specialist I to support a global diagnostics organization in South Portland, Maine. The role focuses on regulatory submissions, product registrations, and quality management for IVD products within Infectious Disease.

This entry-level position requires a scientific/technical background, strong organization, and a growing regulatory expertise to support patient care through infectious disease diagnostics.

Qualifications

• Bachelor's degree in a scientific/technical discipline or equivalent experience.
• 0–2 years of regulatory affairs or related experience.
• Basic understanding of FDA regulations and quality management principles.
• Strong written and verbal communication skills.
• Excellent organizational skills and attention to detail.

Responsibilities

• Prepare and maintain documentation for domestic and international regulatory submissions and product registrations.
• Research regulatory information to support submissions and technical documentation.
• Maintain existing product approvals and marketing authorizations.
• Support U.S. submissions and international registration documentation.
• Maintain regulatory databases and tracking systems.

Skills

Communication

Organization

MS Office

Independent work

Education

Bachelor's degree (Biology/ Chemistry/ Biochemistry/ Microbiology/ Immunology/Engineering)

Tools

Regulatory databases

Job description

Viltis is seeking a detail-oriented Regulatory Affairs Specialist I to support a global diagnostics organization in South Portland, Maine. The role focuses on regulatory submissions, product registrations, and quality management for IVD products within Infectious Disease.

This entry-level position requires a scientific/technical background, strong organization, and a growing regulatory expertise to support patient care through infectious disease diagnostics.