Regulatory Affairs Specialist Jobs in Gurnee, IL
The Director of Regulatory Affairs in the quality control industry plays an essential role in ensuring that the company's products meet all regulatory standards and compliance requirements. This individual oversees the development and implementation of regulatory strategies for new and existing products, supervises the preparation of regulatory submissions, and maintains communication with regulatory authorities. They also monitor changes in regulations, interpret these updates for relevant departments within the company, and implement necessary changes to maintain compliance. They are responsible for setting the company's standards for quality, safety, and efficacy.
To excel in this role, one should possess excellent analytical skills, strategic thinking, and strong leadership abilities. A deep understanding of regulatory guidelines, ability to interpret complex regulations, and excellent communication skills are essential. They should have a degree in a relevant field, along with certifications such as Regulatory Affairs Certification (RAC), Certified Quality Auditor (CQA), and Certified Quality Engineer (CQE). Prior to becoming a Director of Regulatory Affairs, individuals might have roles such as Regulatory Affairs Specialist, Regulatory Affairs Manager, or Quality Control Manager.
- Schaumburg, IL (24 miles from Gurnee, IL)
- 4 days ago
- Schaumburg, IL (24 miles from Gurnee, IL)
- 4 days ago
Senior Compliance Analyst We are adding to our diverse team of experts and are looking to hire those who are committed to building a culture that enables the creation of innovative solutions for...
Principal Regulatory Affairs Specialist, Pharmaceutical Products (Hybrid)
- Cary, IL (18 miles from Gurnee, IL)
- 4 days ago
- Cary, IL (18 miles from Gurnee, IL)
- 4 days ago
Work Flexibility: Hybrid We are currently seeking a Principal Regulatory Affairs Specialist, ( Pharmaceutical Products ) to join our Medical Division....
Senior Auditing & Compliance Analyst
- Riverwoods, IL (14 miles from Gurnee, IL)
- 4 days ago
- Riverwoods, IL (14 miles from Gurnee, IL)
- 4 days ago
The Compliance Analyst, Health & Regulatory Compliance Group will support all members of the Health Regulatory & Compliance Group with managing multiple activities and projects required for...
Sr Global Trade Compliance Analyst
- Northfield, IL (20 miles from Gurnee, IL)
- 5 days ago
- Northfield, IL (20 miles from Gurnee, IL)
- 5 days ago
Job Summary The Sr Global Trade Compliance Analyst (US), you are responsible for ensuring Medline trade compliance by adhering to US import and export regulations. This position supports all US...
- North Chicago, IL (5 miles from Gurnee, IL)
- 7 days ago
- North Chicago, IL (5 miles from Gurnee, IL)
- 7 days ago
Required Experience: 4 years pharmaceutical or industry related experience. 1-2 years in quality systems or cross functional project management Preferred Experience: 5 years pharmaceutical experience...
Regulatory Affairs Associate - CMC (Hybrid)
- North Chicago, IL (5 miles from Gurnee, IL)
- 11 days ago
- North Chicago, IL (5 miles from Gurnee, IL)
- 11 days ago
Certification a plus. 4 years pharmaceutical or industry related experience. 1-2 years in quality systems or cross functional project management....
Principal Regulatory Compliance Specialist
- Lake Forest, IL (10 miles from Gurnee, IL)
- 11 days ago
- Lake Forest, IL (10 miles from Gurnee, IL)
- 11 days ago
Ensures sustaining support of Quality System and regulatory compliance by individually working quality system issues and by executing project work for maintaining quality system capability....
Regulatory Affairs Specialist - Drug/Cosmetic
- Northfield, IL (20 miles from Gurnee, IL)
- 24 days ago
- Northfield, IL (20 miles from Gurnee, IL)
- 24 days ago
Applied knowledge of FDA regulations and guidelines. Ability to evaluate information to determine compliance with standards, laws, and regulations....
- Lincolnshire, IL (13 miles from Gurnee, IL)
- 45+ days ago
- Lincolnshire, IL (13 miles from Gurnee, IL)
- 45+ days ago
Company Description Bosch Rexroth is one of the world's leading providers of Drive and Control Technologies. Regardless of the motion task that customers face anywhere in the world, they will...
Global Cybersecurity Compliance Analyst
- Northbrook, IL (18 miles from Gurnee, IL)
- 28 days ago
- Northbrook, IL (18 miles from Gurnee, IL)
- 28 days ago
audit findings Understands and applies relevant regulatory and legal compliance requirements...
Demographic Data for Gurnee, IL
Moving to Gurnee, IL? Find some basic demographic data about Gurnee, IL below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Gurnee, IL
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Gurnee, IL offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Finance
- Medicaid
- Flexibility
- Call Center Experience
- Medicare
- Internal Control
- Management Reporting
- Fraud Investigation
- Reimbursement
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Medical Device Sales
- FDA Regulations
- Business Processes
- Document Management
- Microsoft Visio
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Risk Management
- Strategy Development
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Reporting
- Data Analysis
- Education Experience
- Interpersonal Skills
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Sales
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Leadership
- Communication Skills
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