Regulatory Affairs Specialist Jobs in Pleasant Prairie, WI
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.
- Deerfield, IL (24 miles from Pleasant Prairie, WI)
- 2 days ago
- Deerfield, IL (24 miles from Pleasant Prairie, WI)
- 2 days ago
at CF Enterprises, Inc. in Deerfield, Illinois, United States Job Description At CF Industries, our mission is to provide clean energy to feed and fuel the world sustainably. Our employees are...
- Deerfield, IL (24 miles from Pleasant Prairie, WI)
- 8 days ago
- Deerfield, IL (24 miles from Pleasant Prairie, WI)
- 8 days ago
Job#: 2071732 Job Description: Compliance Analyst Pay Rate: $26/hr-$35/hr W2 based on experience Location: Hybrid, Chicago, IL OR Deerfield, IL, 3x/week Duration: 6 months, contract to hire...
Technology Risk & Compliance Analyst
- Deerfield, IL (24 miles from Pleasant Prairie, WI)
- 9 days ago
- Deerfield, IL (24 miles from Pleasant Prairie, WI)
- 9 days ago
Job Responsibilities: The Analyst, Technology Risk & Compliance assists with managing and administering tools that support TRC activities, including IT Policy, risk practices, compliance with...
Senior Regulatory Affairs Specialist, Digital Health / Software Products
- Lake Forest, IL (20 miles from Pleasant Prairie, WI)
- 9 days ago
- Lake Forest, IL (20 miles from Pleasant Prairie, WI)
- 9 days ago
As a Senior Regulatory Affairs Specialist within Alcon's Digital Health Quality and Regulatory Affairs (QRA) team, you will be trusted to ensure compliance with regulatory requirements for software...
Senior Auditing & Compliance Analyst
- Riverwoods, IL (24 miles from Pleasant Prairie, WI)
- 15 days ago
- Riverwoods, IL (24 miles from Pleasant Prairie, WI)
- 15 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...
- North Chicago, IL (14 miles from Pleasant Prairie, WI)
- 17 days ago
- North Chicago, IL (14 miles from Pleasant Prairie, WI)
- 17 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 (14 miles from Pleasant Prairie, WI)
- 21 days ago
- North Chicago, IL (14 miles from Pleasant Prairie, WI)
- 21 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 (20 miles from Pleasant Prairie, WI)
- 22 days ago
- Lake Forest, IL (20 miles from Pleasant Prairie, WI)
- 22 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....
- Lincolnshire, IL (23 miles from Pleasant Prairie, WI)
- 45+ days ago
- Lincolnshire, IL (23 miles from Pleasant Prairie, WI)
- 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...
Demographic Data for Pleasant Prairie, WI
Moving to Pleasant Prairie, WI? Find some basic demographic data about Pleasant Prairie, WI below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Pleasant Prairie, WI
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Pleasant Prairie, WI 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
- Institutional Review Board
- Internal Audits
- 21 CFR 820
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Microsoft Visio
- Root Cause Analysis
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Data Analysis
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Sales
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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