Regulatory Affairs Specialist - IVD Diagnostics

MaineGuide; Portland (ME); On-site; USD 28,000 - 34,000; Full time

Job summary

Viltis seeks an early‑career Regulatory Affairs Specialist I to support regulatory submissions and product registrations for IVD diagnostics. The role focuses on domestic and international submissions, change control, and quality documentation within a leading diagnostics organization in South Portland, Maine.

The ideal candidate has a science/engineering background, strong organization, and ability to work across cross‑functional teams to ensure regulatory compliance and timely approvals for

Qualifications

• Bachelor's degree and relevant science/engineering background required.
• Strong written and verbal communication skills, plus attention to detail.
• Experience with regulatory affairs or QA/manufacturing environment is a plus.

Responsibilities

• Prepare and maintain documentation for domestic and international regulatory submissions and registrations.
• Evaluate changes and support change control and labeling/documentation upkeep.
• Maintain regulatory databases and ensure compliance with FDA/ISO quality systems.

Skills

Regulatory submissions

Documentation management

FDA regulations

Cross-functional collaboration

Education

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

Tools

Microsoft Office

Job description

Viltis seeks an early‑career Regulatory Affairs Specialist I to support regulatory submissions and product registrations for IVD diagnostics. The role focuses on domestic and international submissions, change control, and quality documentation within a leading diagnostics organization in South Portland, Maine.

The ideal candidate has a science/engineering background, strong organization, and ability to work across cross‑functional teams to ensure regulatory compliance and timely approvals for