ABBOTT LABORATORIES Clinical Evaluation and Quality System Analyst Salary in the United States

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

Individuals coordinate and support technical and scientific regulatory activities, research regulations and guidance, and maintain and organize key information sources.

Responsibilities

• 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
• Assuring that SOPs and Templates are in accordance with document control processes.
• Creating Change Orders (COs) in order to get documents into the document control system.
• Ensuring audit observations on documentation are properly addressed.
• Crafting corrective action and preventive action (CAPA) for documentation, and helping address the CAPAs.
• Maintaining Key Performance Indicators (KPIs) on documentation and obtaining signatures on COs
• Trending the KPIs.

Qualifications

• 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
• Think analytically and critically
• 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