Regulatory Specialist I

ManpowerGroup Global, Inc.

South Portland (ME)

On-site

USD 33,000 - 39,000

Full time

9 days ago
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Benefits offered by this job

Medical and Prescription Drug Plans
Dental Plan
Vision Plan
Health Savings Account
401(k), Plus Match
Weekly Pay

Job summary

ManpowerGroup Global, Inc. is seeking a Regulatory Specialist I for their South Portland, Maine location. This is a 100% onsite position with a pay range of $24 to $28 per hour on W2.

The role requires compiling and publishing materials for submissions, maintaining licenses, and ensuring compliant product shipments. Candidates should have a Bachelor's Degree in a relevant field and knowledge of Federal Regulations. Proficiency in Microsoft Office is expected.

Qualifications

  • 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.

Responsibilities

  • Compile and publish material for submissions and license renewals.
  • Assist in researching information for submission documents.
  • Maintain approvals and licenses for marketing authorizations.
  • Ensure compliant shipment of products through proper documentation.
  • Assess changes for regulatory impact and compliance.

Skills

Written communication
Verbal communication
Time management
Knowledge of Federal Regulations
Microsoft Office proficiency

Education

Bachelor's Degree in Biology
Bachelor's Degree in Chemistry
Bachelor's Degree in Biochemistry
Bachelor's Degree in Engineering

Tools

Microsoft Word
Microsoft Excel
Microsoft PowerPoint
Microsoft Visio

Job description

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
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