Regulatory Affairs Specialist Jobs in Kentucky
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.
Our mission is to make higher education accessible and affordable for everyone.** We empower students with financial support and supercharge their ability to pay down their debt, so they can get...
Remote WorkAdvertisement Closes 8/7/2025 (8:00 PM EDT) 25-04548 Human Srvs Prog Compliance Analyst (FFTL) Pay Grade 14 Salary $3,575.00 Monthly Employment Type EXECUTIVE BRANCH | FULL TIME | ELIGIBLE FOR...
Associate Compliance Analyst - eMonitoring As a member of the Social Media and eCommunications team, the Associate Compliance Analyst has the responsibility of reviewing and acting on all alerted...
Business Intelligence and Compliance Analyst- REMOTE
- Frankfort, KY
- 8 days ago
- Frankfort, KY
- 8 days ago
Job Seekers can review the Job Applicant Privacy Policy by clicking here ( ). Job Description : Summary The Business Intelligence, Analytics & Reporting Analyst will gather, analyze, and...
Remote WorkQuality Assurance and Regulatory Affairs Associate II
- Louisville, KY
- 12 days ago
- Louisville, KY
- 12 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...
Regulatory Compliance Specialist Position Summary Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply...
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:...
Tempur Sealy is proud to be an Equal Employment Opportunity and Affirmative Action employer. We provide equal employment opportunities to all employees and applicants for employment and prohibit...
Demographic Data for Kentucky
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Kentucky
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Kentucky 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
- ISO 13485
- Corrective Actions & Preventive Actions
- Medical Device Sales
- Business Processes
- FDA Regulations
- Resolution
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Quality Assurance
- Process Improvement
- Auditing
- Military Background
- Implementation
- Analytical Skills
- Investigation
- Written Communication
- Education Experience
- Verbal Communication
- Documentation
- Data Analysis
- Reporting
- Collaboration
- Policy Development
- Filing
- Microsoft PowerPoint
- Bachelor's Degree
- Regulations
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Customer Service
- Scheduling
- Leadership
- Communication Skills
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