Regulatory Affairs Specialist Jobs in Naperville, 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 (18 miles from Naperville, IL)
- 3 days ago
- Schaumburg, IL (18 miles from Naperville, IL)
- 3 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...
Compliance Analyst Accounts Payable, Full time - Days
- Burr Ridge, IL (10 miles from Naperville, IL)
- 29 days ago
- Burr Ridge, IL (10 miles from Naperville, IL)
- 29 days ago
Collaborate with the internal audit team to support broader compliance initiatives. Review and approve vendor setup and updates in the ERP system to ensure data accuracy and policycompliance....
- Niles, IL (24 miles from Naperville, IL)
- 30+ days ago
- Niles, IL (24 miles from Naperville, IL)
- 30+ days ago
THE OPPORTUNITY: We are seeking a highly motivated and detail-oriented individual to join our team as a Regulatory Affairs Specialist for a 9 month contract....
Senior Contract Compliance Analyst
- Downers Grove, IL (6 miles from Naperville, IL)
- 30+ days ago
- Downers Grove, IL (6 miles from Naperville, IL)
- 30+ days ago
at Illinois Tollway in Downers Grove, Illinois, United States Job Description Position Overview The Illinois Tollway is dedicated to providing and promoting a safe and efficient system of highways...
Demographic Data for Naperville, IL
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Naperville, IL
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Naperville, 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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