Regulatory Specialist I

Job Title: Regulatory Specialist I
Location: South Portland, Maine - 100% Onsite 
Pay Range: $24 to $28/hr on W2 

What's the Job?

  • Compile and publish all material required for submissions, license renewals, and annual registrations.
  • Assist in researching scientific and regulatory information to prepare submission documents.
  • Maintain approvals, licenses, and authorizations for existing marketing authorizations.
  • Ensure compliant shipment of products through proper documentation and record-keeping.
  • Assess product, manufacturing, and labeling changes for regulatory impact and compliance.

What's Needed?

  • Bachelor's Degree in Biology, Chemistry, Biochemistry, Engineering, or related technical field.
  • Knowledge of Federal Regulations and standards affecting IVDs and biologics.
  • Demonstrated written and verbal communication skills.
  • Strong time management skills with the ability to handle multiple projects simultaneously.
  • Proficiency with Microsoft Office applications including Word, Excel, PowerPoint, and Visio.

Upon completion of waiting period consultants are eligible for:

  • Medical and Prescription Drug Plans
  • Dental Plan
  • Vision Plan
  • Health Savings Account
  • Health Flexible Spending Account
  • Dependent Care Flexible Spending Account
  • Supplemental Life Insurance
  • Short Term and Long Term Disability Insurance
  • Business Travel Insurance
  • 401(k), Plus Match
  • Weekly Pay

If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

South Portland, ME

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