Regulatory Affairs Specialist Jobs in Nashville, 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.
Company Overview HealthStream is the leader in healthcare workforce solutions. We help organizations work better by helping their people work smarter. HealthStream provides the leading learning,...
. + 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 WorkPrimary responsibilities and functions include: Serves as subject matter expert with regard to compliance operations within the Oracle Cloud Infrastructure, based on strong knowledge of US...
Company Overview Bridgestone Americas, Inc. (BSAM), headquartered in Nashville, Tennessee, and Bridgestone Europe, Middle East and Africa (BSEMEA), headquartered in Brussels, Belgium, operate...
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Company Overview Bridgestone Americas, Inc. (BSAM), headquartered in Nashville, Tennessee, and Bridgestone Europe, Middle East and Africa (BSEMEA), headquartered in Brussels, Belgium, operate...
Description Introduction Do you want to join an organization that invests in you as a Senior Compliance Analyst? At HCA Healthcare, you come first. HCA Healthcare has committed up to 300 million...
- Franklin, TN (22 miles from Nashville, TN)
- 30+ days ago
- Franklin, TN (22 miles from Nashville, TN)
- 30+ days ago
Description Introduction Do you want to join an organization that invests in you as a Senior Compliance Analyst? At HCA Healthcare, you come first. HCA Healthcare has committed up to $300 million...
Payment Compliance Analyst Work from Home Nashville, TN, United States schedule Full-time Work From Home Admitting Registration Clerical and Scheduling Job ID: 3240943 Description Introduction...
Remote WorkSenior Governance, Risk & Compliance Analyst
- Franklin, TN (22 miles from Nashville, TN)
- 60+ days ago
- Franklin, TN (22 miles from Nashville, TN)
- 60+ 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 Nashville, TN
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Nashville, TN
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Nashville, 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 Control
- Reimbursement
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- Validation
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Resolution
- Product Development
- Affirmative Action
- Engineering
- Risk Management
- Strategy Development
- Process Improvement
- Military Background
- Auditing
- Analytical Skills
- Implementation
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Data Analysis
- Collaboration
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Reporting
- 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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