Regulatory Affairs Specialist Jobs in New Port Richey, FL
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.
- Clearwater, FL (18 miles from New Port Richey, FL)
- 2 days ago
- Clearwater, FL (18 miles from New Port Richey, FL)
- 2 days ago
The Compliance Analyst is responsible for ensuring employees comply with various federal and state healthcare regulations and policies, and for conducting training of new and existing employees...
Governance Risk Compliance Analyst III
- Palm Harbor, FL (11 miles from New Port Richey, FL)
- 17 days ago
- Palm Harbor, FL (11 miles from New Port Richey, FL)
- 17 days ago
Job Summary: Members of the Governance/Risk/Compliance Section assure the risk posture of the organization is being adequately managed while maintaining related project plans. GSI is a highly...
Governance, Risk & Compliance Analyst I
- Palm Harbor, FL (11 miles from New Port Richey, FL)
- 60+ days ago
- Palm Harbor, FL (11 miles from New Port Richey, FL)
- 60+ days ago
Job Summary: The Governance, Risk, & Compliance Analyst I will assist the team in the completion of audits, identification and reporting of all security issues, prioritizing threats, and...
Demographic Data for New Port Richey, FL
Moving to New Port Richey, FL? Find some basic demographic data about New Port Richey, FL below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in New Port Richey, FL
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in New Port Richey, FL offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Finance
- Vendor Management
- Internal Control
- Management Reporting
- Operations Analysis
- Internal Audits
- 21 CFR 820
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Standard Operating Procedures
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Quality Assurance
- Process Improvement
- Auditing
- Implementation
- Military Background
- Analytical Skills
- Investigation
- Written Communication
- Verbal Communication
- Education Experience
- Data Analysis
- Collaboration
- Documentation
- Reporting
- Filing
- Regulations
- Bachelor's Degree
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Sales
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Customer Service
- Scheduling
- Leadership
- Communication Skills
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