Regulatory Affairs Specialist Jobs in Columbia, TN
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.
Payment Compliance Analyst - REMOTE
- Franklin, TN (15 miles from Columbia, TN)
- 7 days ago
- Franklin, TN (15 miles from Columbia, TN)
- 7 days ago
The Payment Compliance & Contract Management (PCCM) Analyst - REMOTE is responsible for maximizing reimbursement by identifying variances between posted and expected revenue for managed care,...
Remote WorkSenior Governance, Risk & Compliance Analyst
- Franklin, TN (15 miles from Columbia, TN)
- 90+ days ago
- Franklin, TN (15 miles from Columbia, TN)
- 90+ days ago
audits through to completion Become an expert on organizations security, privacy, and risk frameworks and controls Learn about the organization's products, use of AI, data use and risk tolerance....
Demographic Data for Columbia, TN
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Columbia, TN
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Columbia, TN offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Corrective Actions & Preventive Actions
- Medical Device Sales
- Business Processes
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Product Development
- Affirmative Action
- Engineering
- Risk Management
- Military Background
- Analytical Skills
- Implementation
- Auditing
- Investigation
- Verbal Communication
- Writing Skills
- Data Analysis
- Written Communication
- Collaboration
- Documentation
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Sales
- Microsoft Excel
- Microsoft Word
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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