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.
. + Own audit readiness and guide teams through federal and state exams, internal audits, and testing processes with confidence and clarity. + Turn insights into action by analyzing results, delivering...
Remote WorkAdvertisement Closes 4/30/2025 (8:00 PM EDT) 25-02546 Human Srvs Prog Compliance Analyst Pay Grade 14 Salary $41,952.48 - $62,928.48 Annually Employment Type EXECUTIVE BRANCH | FULL TIME |...
Remote WorkSALARY The minimum salary is $24.143 per hour This position is eligible for overtime (non-exempt), if applicable. Pay Grade 518 FILING DEADLINE DATE The deadline to apply is Monday, May 12, 2025....
Otsuka Pharmaceuticals - Trade Compliance Analyst** **Position Summary:** + Provide technical and analytical support for customs and trade compliance matters at the North Americasite/division(s)...
Your Future Evolves Here Evolent partners with health plans and providers to achieve better outcomes for people with most complex and costly health conditions. Working across specialties and...
LICENSES or CERTIFICATIONS Required None Preferred (any of the following) Certified in Healthcare Compliance (CHC) Certified Healthcare Internal Audit Professional (CHIAP) SKILLS Demonstrate expert...
Senior Regulatory Affairs Specialist - Central Labs
- Highland Heights, KY
- 29 days ago
- Highland Heights, KY
- 29 days ago
ThermoFisher Scientific Senior Regulatory Affairs Specialist - Central Labs in Highland Heights , Kentucky Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Thermo Fisher...
University of Kentucky Equal Employment Opportunity/M/F/disability/protected veteran status. Posting Details Posting Details Job Title STEPS Records Compliance Analyst Requisition Number TE08763...
We're currently seeking a passionate and enthusiastic Regulatory Affairs Specialist to join our growing team....
Demographic Data for Kentucky
Moving to Kentucky? Find some basic demographic data about Kentucky below.
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
- Medicaid
- Flexibility
- Call Center Experience
- Medicare
- Internal Control
- Management Reporting
- Fraud Investigation
- Reimbursement
- Institutional Review Board
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- 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
- Military Background
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Data Analysis
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
Other Career Titles
Here are some other career titles that require similar skills
Regulatory Affairs Specialist Related Career Advice Articles
Top Skills and Quality Control Training You Need to Get Promoted
Ready to take your quality control career to the next level? Seek out quality control training for these highly desired skills for quality control jobs.
Read article »