Regulatory Affairs Specialist Jobs in Augusta, KS
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.
- Wichita, KS (16 miles from Augusta, KS)
- 7 days ago
- Wichita, KS (16 miles from Augusta, KS)
- 7 days ago
JOB SUMMARY\: Supply chain professional with a background in business intelligence, data analysis and process improvement. The Supply Chain Compliance Specialist is responsible for supporting...
Senior Ethics & Compliance Analyst
- Wichita, KS (16 miles from Augusta, KS)
- 13 days ago
- Wichita, KS (16 miles from Augusta, KS)
- 13 days ago
_When applicable, Bombardier promotes flexible and hybrid work policies._ **Why join us?** At Bombardier, we design, build and maintain the worlds peak-performing aircraft for the worlds most...
- Wichita, KS (16 miles from Augusta, KS)
- 30+ days ago
- Wichita, KS (16 miles from Augusta, KS)
- 30+ days ago
Job Overview: Join our team as a Compliance Analyst, where you’ll play a key role in supporting the Bank’s compliance efforts by ensuring adherence to regulatory requirements related to retail...
Demographic Data for Augusta, KS
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Augusta, KS
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Augusta, KS offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Finance
- Internal Control
- Management Reporting
- Operations Analysis
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Corrective Actions & Preventive Actions
- Business Processes
- Medical Device Sales
- FDA Regulations
- Resolution
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Process Improvement
- Auditing
- Military Background
- Implementation
- Analytical Skills
- Investigation
- Written Communication
- Education Experience
- Verbal Communication
- Documentation
- Data Analysis
- Reporting
- Collaboration
- Interpersonal Skills
- Filing
- Microsoft PowerPoint
- Bachelor's Degree
- Policy Development
- Regulations
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Sales
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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