6 Jobs in Northfield, IL
Medline is Hiring a Regulatory specialist Near Northfield, IL
Regulatory Labeling Specialist (
Job Number : QUA0101YE )
QUA0101YE )
Primary Location
US-IL-Northfield
Description
JOB SUMMARY :
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.
- 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).
Qualifications
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.
Last updated : 2024-06-11
Job Summary
Full Time
Medical Technology
$66k-86k (estimate)
06/13/2024
09/12/2024
medline.com
NORTHFIELD, IL
15,000 - 50,000
1966
Private
CHARLES MILLS
$200M - $500M
Medical Technology
Related Companies
About Medline
Medline is an Illinois-based company that manufactures and distributes medical equipment such as apparel, nursing supplies and surgery devices for the healthcare industry.
The job skills required for Regulatory specialist include Regulatory Affairs, Problem Solving, Project Management, Quality Management System, etc. Having related job skills and expertise will give you an advantage when applying to be a Regulatory specialist. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Regulatory specialist. Select any job title you are interested in and start to search job requirements.
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Quotes from people on Regulatory Specialist job description and responsibilities
The regulatory specialist creates and maintains regulations for testing processes, the development phase, how production operates and the marketing and distribution for new products.
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works to help a company or organization meet all state, local, federal, international, and industrial regulations that apply to their products.
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Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.
Career tips from people on Regulatory Specialist jobs
Entry-level regulatory affairs professionals must have a bachelor’s degree.
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Successful regulatory specialists are excellent writers, as they must write details and accurate reports for the evaluations they perform.
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Earn Regulatory Affairs Professionals Society certifications.
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On successful completion of the program, graduates can take up roles such as regulatory affairs specialists.
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At conferences and forums, specialists develop their existing knowledge and learn about emerging regulations, standards, and guidance documents.
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Step 3: View the best colleges and universities for Regulatory Specialist.
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