Regulatory Affairs Specialist Jobs in Ringwood, 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.
- North Chicago, IL (23 miles from Ringwood, IL)
- 5 days ago
- North Chicago, IL (23 miles from Ringwood, IL)
- 5 days ago
Description: New manufacturing site in France due to acquiring new business. Complete 3 separate projects for CMC clinical/regulatory submissions. Responsible for filing necessary applications and...
Regulatory Affairs Associate II
- North Chicago, IL (23 miles from Ringwood, IL)
- 5 days ago
- North Chicago, IL (23 miles from Ringwood, IL)
- 5 days ago
Familiar with pharmaceutical master batch records and how to author CMC submissions for clinical studies. Technical writing skills Familiar with typical manufacturing processes, especially cell...
Senior Specialist - Regulatory Affairs -Transfusion
- Lake Bluff, IL (24 miles from Ringwood, IL)
- 45+ days ago
- Lake Bluff, IL (24 miles from Ringwood, IL)
- 45+ days ago
Abbott Park : AP08/A ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: No MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2...
Demographic Data for Ringwood, IL
Moving to Ringwood, IL? Find some basic demographic data about Ringwood, IL below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Ringwood, IL
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Ringwood, 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
- Vendor Management
- Cross-Functional Team Management
- Internal Control
- Management Reporting
- Operations Analysis
- Internal Audits
- 21 CFR 820
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Quality Assurance
- Process Improvement
- Auditing
- Implementation
- Military Background
- Analytical Skills
- Investigation
- Written Communication
- Verbal Communication
- Education Experience
- Data Analysis
- Collaboration
- Documentation
- Reporting
- Filing
- Regulations
- Bachelor's Degree
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Sales
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Customer Service
- Scheduling
- Leadership
- Communication Skills
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