Regulatory Affairs Specialist Jobs in Coral Gables, 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.
Compliance Analyst III-AML CIU International
- Miami, FL (5 miles from Coral Gables, FL)
- 12 hours ago
- Miami, FL (5 miles from Coral Gables, FL)
- 12 hours ago
The Compliance Analyst III-Anti-Money Laundering (AML) Client Intelligence Unit (CIU) International systematically reviews high-risk clients from a risk-based approach. The AML CIU Analyst...
Regulatory Compliance Analyst (On-site)
- Miami, FL (5 miles from Coral Gables, FL)
- 2 days ago
- Miami, FL (5 miles from Coral Gables, FL)
- 2 days ago
The Compliance Analyst's primary function is to ensure Educational Federal Credit Union's compliance with all applicable regulatory requirements. This position coordinates compliance initiatives...
Principal Compliance Analyst - IT
- Miami, FL (5 miles from Coral Gables, FL)
- 30+ days ago
- Miami, FL (5 miles from Coral Gables, FL)
- 30+ days ago
The Lead Analyst, IT Compliance is responsible for developing and documenting strategies that ensure that IT practices adhere to relevant laws, regulations, and industry standards, such as...
- Hallandale Beach, FL (19 miles from Coral Gables, FL)
- 45+ days ago
- Hallandale Beach, FL (19 miles from Coral Gables, FL)
- 45+ days ago
Compliance Analyst Human Resources - Hallandale Beach, Florida About the company: Kawa, an independent asset manager based in Hallandale Beach, FL, was founded in 2007. Kawa Capital has a proven...
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Facilities Quality & Compliance Analyst 1
- Miami, FL (5 miles from Coral Gables, FL)
- 60+ days ago
- Miami, FL (5 miles from Coral Gables, FL)
- 60+ days ago
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn...
Regulatory Compliance Specialist 2
- Miami, FL (5 miles from Coral Gables, FL)
- 90+ days ago
- Miami, FL (5 miles from Coral Gables, FL)
- 90+ days ago
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn...
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Coral Gables, FL
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Coral Gables, 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
- 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
- Microsoft SharePoint
- Product Development
- Risk Management
- Engineering
- Strategy Development
- Process Improvement
- Military Background
- Implementation
- Auditing
- Analytical Skills
- 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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