Regulatory Specialist I — Global Submissions

Us Tech Solutions; South Portland (ME); On-site; USD 65,000 - 90,000; Full time

Job summary

US Tech Solutions is seeking a Regulatory Affairs Specialist I for the Infectious Disease unit in Scarborough, Maine. With aBachelor’s degree in science, you’ll support domestic and international product registrations and contribute to regulatory submissions with guidance.

You will compile documents, research regulatory information, maintain licenses, ensure compliant shipping, and assist in procedures aligned with ISO and FDA standards. This is a 12-month position at a global services firm.

Qualifications

• Knowledge of Federal Regulations and regulatory submissions.
• 0-2 years regulatory experience or related industrial exposure.
• Strong written and verbal communication skills; problem solving abilities.

Responsibilities

• Compiles and publishes material for submissions, license renewals and registrations.
• Assists in researching regulatory information to write submission documents.
• Maintains approvals and licenses for existing marketing authorizations.
• Ensures compliant shipment of products and maintains related data.
• Assesses changes for regulatory reporting impact and compliance.
• Organizes department files and stays informed on global regulatory information.
• Participates in developing internal procedures and tools.
• Adheres to ISO, FDA and other regulatory agency requirements.

Skills

Regulatory knowledge

Time management

Independent & team work

Education

Science degree

Tools

Microsoft Office

QMS familiarity

Job description

US Tech Solutions is seeking a Regulatory Affairs Specialist I for the Infectious Disease unit in Scarborough, Maine. With aBachelor’s degree in science, you’ll support domestic and international product registrations and contribute to regulatory submissions with guidance.

You will compile documents, research regulatory information, maintain licenses, ensure compliant shipping, and assist in procedures aligned with ISO and FDA standards. This is a 12-month position at a global services firm.