Regulatory Affairs Specialist Jobs in Cold Spring, 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.
Corporate Health & Wellness - Sr. Compliance Analyst
- Cincinnati, OH (10 miles from Cold Spring, KY)
- 8 days ago
- Cincinnati, OH (10 miles from Cold Spring, KY)
- 8 days ago
Responsible for the management of a wide range of data, including gathering, analyzing and summarizing data necessary for Health & Wellness compliance, quality related activities, and continuous...
- Cincinnati, OH (19 miles from Cold Spring, KY)
- 10 days ago
- Cincinnati, OH (19 miles from Cold Spring, KY)
- 10 days ago
SUMMARY The Compliance Analyst I is responsible for assisting compliance officers in support of their Rule 38a-1 compliance program obligations for the clients of Ultimus Fund Solutions (UFS.)...
- Cincinnati, OH (10 miles from Cold Spring, KY)
- 16 days ago
- Cincinnati, OH (10 miles from Cold Spring, KY)
- 16 days ago
Affairs Specialist to join our team....
Vendor Compliance Analyst Cincinnati, OH, US 2 days agoFull Time
- Cincinnati, OH (10 miles from Cold Spring, KY)
- 30+ days ago
- Cincinnati, OH (10 miles from Cold Spring, KY)
- 30+ days ago
Vendor Compliance Analyst Full Time Professional Cincinnati, OH, US 2 days ago Requisition ID: 1935 Scope of Job: The Vendor Compliance Analyst is responsible for monitoring vendor performance,...
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Senior Contract Compliance Analyst, Administration & Finance, Hybrid University of Cincinnati
- Cincinnati, OH (10 miles from Cold Spring, KY)
- 30+ days ago
- Cincinnati, OH (10 miles from Cold Spring, KY)
- 30+ days ago
Current UC employees must apply internally via SuccessFactors Founded in 1819, the University of Cincinnati ranks among the nation?s best urban public research universities. Home to 53,235...
Senior Contract Compliance Analyst, Administration & Finance, Hybrid
- Cincinnati, OH (10 miles from Cold Spring, KY)
- 30+ days ago
- Cincinnati, OH (10 miles from Cold Spring, KY)
- 30+ days ago
Current UC employees must apply internally via SuccessFactors Founded in 1819, the University of Cincinnati ranks among the nations best urban public research universities. Home to 53,235...
Demographic Data for Cold Spring, KY
Moving to Cold Spring, KY? Find some basic demographic data about Cold Spring, KY below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Cold Spring, KY
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Cold Spring, 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
- Internal Control
- Reimbursement
- Institutional Review Board
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- Validation
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Microsoft Visio
- Resolution
- Product Development
- Affirmative Action
- Engineering
- Risk Management
- Strategy Development
- Process Improvement
- Military Background
- Implementation
- Analytical Skills
- 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
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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