Regulatory Affairs Associate, IVD Medical Devices

Viltis; Maple Grove (MN); On-site; USD 60,000 - 70,000; Full time

Job summary

Viltis, a global diagnostics organization, seeks a detail-oriented Regulatory Affairs Specialist I to support regulatory submissions, product registrations, and quality management for IVD products in South Portland, Maine. The role focuses on domestic and international submissions within the Infectious Disease unit and requires strong organizational skills and a scientific background.

Ideal candidates have 0–2 years in regulatory affairs, familiarity with FDA regulations, and the ability to

Qualifications

• Bachelor's degree in biology or related field required.
• 0-2 years of regulatory affairs or related field.
• Basic understanding of FDA regulations and quality management.
• Strong written and verbal communication skills.
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint).
• Ability to work both independently and in cross-functional teams.
• Excellent organizational skills and attention to detail.

Responsibilities

• Prepare, compile, and maintain documentation for domestic and international regulatory submissions.
• Research scientific and regulatory information to support submissions.
• Maintain existing product approvals, licenses, and marketing authorizations.
• Support U.S. regulatory submissions and international registration documentation.
• Maintain accurate information in global regulatory databases and tracking systems.

Skills

Communication skills

Organizational skills

Multitasking

MS Office

Team collaboration

Education

Bachelor's degree in Biology, Chemistry, Biochemistry, Microbiology, Immunology, Medical Technology, Engineering, or related field

Tools

Regulatory databases

Document control systems

Job description

Viltis, a global diagnostics organization, seeks a detail-oriented Regulatory Affairs Specialist I to support regulatory submissions, product registrations, and quality management for IVD products in South Portland, Maine. The role focuses on domestic and international submissions within the Infectious Disease unit and requires strong organizational skills and a scientific background.

Ideal candidates have 0–2 years in regulatory affairs, familiarity with FDA regulations, and the ability to