Regulatory Affairs Specialist Jobs in Boca Raton, 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.
Interpret and apply Federal Acquisition Regulations (FAR) to ensure compliance across projects and departments Prepare and review Incurred Cost Submissions (ICE) Support and manage interactions...
Interpret and apply Federal Acquisition Regulations (FAR) to ensure compliance across projects and departments Prepare and review Incurred Cost Submissions (ICE) Support and manage interactions...
Research Regulatory Affairs Specialist I
- West Palm Beach, FL (24 miles from Boca Raton, FL)
- 1 day ago
- West Palm Beach, FL (24 miles from Boca Raton, FL)
- 1 day ago
Date Posted: 2025-07-29 Country: United States of America Location: Flagler Office WHY JOIN FCS At Florida Cancer Specialists & Research Institute, we believe our people are our strength and we...
Remote WorkCompliance Analyst- Corporate Compliance-BHC-FT-#21613
- Fort Lauderdale, FL (16 miles from Boca Raton, FL)
- 4 days ago
- Fort Lauderdale, FL (16 miles from Boca Raton, FL)
- 4 days ago
Broward Health Corporate ISC Shift: Shift 1 FTE: 1.000000 Summary: Are you looking to start a career in healthcare compliance? The Compliance Analyst role offers a strong foundation in the key...
DEA Compliance Analyst - Weston, FL (HYBRID)
- Weston, FL (24 miles from Boca Raton, FL)
- 60+ days ago
- Weston, FL (24 miles from Boca Raton, FL)
- 60+ days ago
Who we are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across...
- Davie, FL (19 miles from Boca Raton, FL)
- 90+ days ago
- Davie, FL (19 miles from Boca Raton, FL)
- 90+ days ago
Who we are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across...
Demographic Data for Boca Raton, FL
Moving to Boca Raton, FL? Find some basic demographic data about Boca Raton, FL below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Boca Raton, FL
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Boca Raton, 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
- Consulting
- Internal Control
- Management Reporting
- Operations Analysis
- Internal Audits
- 21 CFR 820
- ISO 13485
- Corrective Actions & Preventive Actions
- Business Processes
- Medical Device Sales
- FDA Regulations
- Resolution
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Process Improvement
- Auditing
- Military Background
- Implementation
- Analytical Skills
- Investigation
- Written Communication
- Education Experience
- Verbal Communication
- Documentation
- Data Analysis
- Reporting
- Collaboration
- Interpersonal Skills
- Filing
- Microsoft PowerPoint
- Bachelor's Degree
- Policy Development
- Regulations
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Sales
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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