What are the responsibilities and job description for the Regulatory Specialist I position at GForce Life Sciences?
Regulatory Affairs Specialist
12-month Contract
Onsite in South Portland, ME
Must be able to work on a W2
What You’ll Do
12-month Contract
Onsite in South Portland, ME
Must be able to work on a W2
What You’ll Do
- Compile, assemble, and publish materials for regulatory submissions, license renewals, and annual registrations
- Research scientific and regulatory information to help draft submission documents
- Maintain approvals/licenses/authorizations for existing marketing authorizations
- Support compliant product shipment by maintaining required inclusions (e.g., spreadsheets and related documentation)
- Update and maintain information in the Global Regulatory Information Database
- Assess manufacturing and labeling changes for regulatory reporting impact and compliance
- Organize and maintain department records (electronic and hard copy)
- Stay current on global regulatory requirements and help develop internal procedures/tools
- Work in alignment with Abbott’s Quality Management Systems (ISO, FDA, and other regulatory agencies)
- Bachelor’s degree in Biology, Chemistry, Biochemistry, Engineering, or related technical field (or equivalent education/experience)
- 0–2 years regulatory and/or relevant industry experience
- Knowledge of federal regulations
- Strong written and verbal communication skills
- Ability to manage multiple priorities and work independently and as part of a team
- Proficiency with Microsoft Office (Word, Excel, PowerPoint, Visio)
- Familiarity with regulations/standards impacting IVDs and/or biologics
- Experience supporting change control, labeling/documentation, or quality system activities