Under general supervision, responsible for aligning product labeling content with state and federal regulations.
MAJOR RESPONSIBILITIES:
Review, verify and complete packaging submissions to authorize label related content based on regulations and product claims. Evaluate supporting documentation for relevant regulatory authorities.
Research changes with regulations and review requirements for devices and OTC drugs with stakeholders.
Inform divisions on requirements and content using documentation, market knowledge, and assessment of risk. Influence change to improve processes and eliminate waste.
Identify and execute opportunities for improvement through the simple kaizen process.
Participate in the CTIQ team/Cross departmental team process improvement program.
Conduct internal audits (files, processes, databases, etc.) and maintain department databases, logs and files.
Train and mentor new employees, divisional QA's and product managers on regulatory product structure, regulatory labeling requirements, and Medline labeling procedure(s).
Education
Bachelor's Degree in Science or related field.
Work Experience
At least 2 years of experience in Quality or Regulatory Affairs for a regulated industry.
Knowledge / Skills / Abilities
Knowledge and understanding of FDA product codes and product class structure, Quality Management Systems and Good Manufacturing Practices, or willingness to learn through training and independent research.
Excellent communication and relationship building skills, project management, critical thinking and problem solving abilities to deliver results and meet deadlines.
PREFERRED JOB REQUIREMENTS
At least 2 years of experience in a product labeling-related role for a regulated industry.
Experience evaluating regulatory risk.
Experience in project management using critical thinking and problem solving abilities to deliver results.
Experience in evaluation of information to determine compliance with standards, laws, and regulations.
