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.
- 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
Regulatory Specialist I in south portland at Unknown Company
This position is listed as full time and onsite.