Abbott Regulatory Affairs Specialist - I in Sylmar, California
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.
Individuals coordinate and support technical and scientific regulatory activities, research regulations and guidance, and maintain and organize key information sources.
Provides support for regulatory processes and procedures.
Maintains current registrations by preparing documentation required and submitting documentation on schedule as directed.
Completes daily work to meet established schedule with guidance from supervisor on prioritization of tasks.
May exercise authority within pre-established limits and approval.
Failure to achieve results can normally be overcome without serious effect on the business.
Medical and regulatory terminology
Regulatory history, guidelines, policies, standards, practices, requirements and precedents
Regulatory agency structure, processes and key personnel
Principles and requirements of applicable product laws
Submission/registration types and requirements
GxPs (GCPs, GLPs, GMPs)
Principles and requirements of promotion, advertising and labeling
Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.
2+ years experience in a regulated industry (e.g., medical products, nutritionals). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
Strong attention to detail
Handle detailed tasks and prioritize them
Think analytically and critically
Review and analyze documentation
Work on projects/problems of limited scope
Research and locate information on regulatory requirements and similar products
Exercises judgment within defined procedures and practices to determine appropriate action
General knowledge of technical alternatives and an understanding of their impact on the systems environment
Apply business ethical standards
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 email@example.com