Abbott Sr. RA Coordinator in Plymouth, Minnesota
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
As an individual contributor, the function of a Regulatory Affairs Coordinator is to provide administrative
support for regulatory processes and procedures. The individual may coordinate and support technical and
scientific regulatory activities, research regulations and guidance, and organize and maintain key information
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Core job responsibilities for this function may include:
· SOP and other document maintenance
· Maintain records on legislation, regulations and guidelines
· Assist in monitoring and reporting project timelines
· Organize materials from preclinical and clinical studies for review
· Compile and organize materials for presubmission reports
· Assist in the preparation of submission/registration packages
· Coordinate registration requests and track completion
· Monitor applications under regulatory review
· Update and maintain paper/electronic document regulatory files and archival systems
· Assist in the preparation of routine reports and regulatory agency communications
· Prepare legal documents for registrations, tenders/bids or other purposes
· Assist with internal audits and inspections
· Assist in the preparation of postmarket reports and submissions
· Update and maintain global product listings, facility registrations, licenses/approvals, and annual
High school diploma or equivalent; Associate's or Bachelor's degree in a technical area (such as biology,
chemistry, engineering, microbiology, immunology, medical technology, pharmacy) is preferred.
0-2 years experience in a regulated business environment (e.g., legal office, regulated industry) is preferred.
Communicate effectively verbally and in writing
Work with departmental teams
Understand business and regulatory ethical standards
Learn to write technical documents
Pay strong attention to detail
Research and locate information on regulatory requirements and products
Learn to use professional concepts and company policies and procedures to solve routine problems
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org