Regulatory Specialist I

GForce Life Sciences; South Portland (ME); Presencial; USD 39.000 - 58.000; Jornada completa

Descripción de la vacante

Abbott is seeking a Regulatory Affairs Specialist for a 12-month contract, onsite in South Portland, ME. You will compile materials for regulatory submissions, renewals, and registrations, and research regulatory information to draft submission documents.

Ideal candidates hold a Bachelor’s degree in biology/related field with 0–2 years of regulatory experience, strong communication skills, and proficiency with Microsoft Office.

Formación

• Bachelor’s degree required or equivalent experience.
• 0–2 years regulatory and/or industry experience preferred.
• 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).

Responsabilidades

• 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).

Conocimientos

Regulatory knowledge

Written and verbal communication

Multitasking

Microsoft Office

Independent worker

Educación

Bachelor’s degree in Biology, Chemistry, Biochemistry, Engineering, or related field

Descripción del empleo

• 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)

Regulatory Affairs Specialist

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)

Must-Have Qualifications

• 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)

Nice-to-Have

• Familiarity with regulations/standards impacting IVDs and/or biologics
• Experience supporting change control, labeling/documentation, or quality system activities