Regulatory Affairs Specialist Jobs in Louisville, KY
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.
Enterprise Compliance Analyst III
- Jeffersonville, IN (4 miles from Louisville, KY)
- 5 days ago
- Jeffersonville, IN (4 miles from Louisville, KY)
- 5 days ago
Summary of This Role Performs and assists in development of enterprise-level risk management and operational compliance functions. Assists in establishing and maintaining risk policies and...
Quality Assurance and Regulatory Affairs Associate II
- Louisville, KY
- 14 days ago
- Louisville, KY
- 14 days ago
Quality Assurance and Regulatory Affairs Associate II Quicksilver Scientific, Inc Louisville, CO, USA 5 days ago Quick Job type Full-time Quick Job description Quicksilver Scientific is a leading...
Description This position is located at our Louisville, KY campus* You Can Change the Life of One to Care for the Lives of Many! At Galen College of Nursing, we educate and empower nurses to...
Department: Information Technology, Information Security Reports to: Director, Cybersecurity Risk Management FLSA Status: Exempt Located In: Louisville, KY Travel: 5%-15% as needed Supervises:...
Demographic Data for Louisville, KY
Moving to Louisville, KY? Find some basic demographic data about Louisville, KY below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Louisville, KY
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Louisville, KY offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Finance
- Consulting
- Internal Control
- Management Reporting
- Operations Analysis
- Internal Audits
- 21 CFR 820
- 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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