Regulatory Affairs Specialist Jobs in Prosper, TX
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.
- Farmers Branch, TX (23 miles from Prosper, TX)
- moments ago
- Farmers Branch, TX (23 miles from Prosper, TX)
- moments ago
The Company Neora, LLC has established a direct sales business model that provides our products to customers around the globe via thousands of direct sales Brand Partners, resulting in aggressive...
- Coppell, TX (23 miles from Prosper, TX)
- 7 days ago
- Coppell, TX (23 miles from Prosper, TX)
- 7 days ago
At home Global logistics team is seeking a motivated individual to join our company as trade Compliance analyst to join our company as a Trade Compliance Analyst to support global trade operations...
Regulatory Affairs Specialist III (Plano, TX)
- Plano, TX (15 miles from Prosper, TX)
- 9 days ago
- Plano, TX (15 miles from Prosper, TX)
- 9 days ago
In-depth knowledge of ISO 13485, FDA regulations (including 21 CFR Part 820), and EU MDR. Knowledge of ISO 14971 risk management for medical devices....
Audit Regulatory Affairs Specialist
- Richardson, TX (20 miles from Prosper, TX)
- 13 days ago
- Richardson, TX (20 miles from Prosper, TX)
- 13 days ago
Job Summary This position is responsible for conducting of regulatory exam and internal audits independently in accordance with Management direction....
- Carrollton, TX (22 miles from Prosper, TX)
- 30+ days ago
- Carrollton, TX (22 miles from Prosper, TX)
- 30+ days ago
Sanmina Corporation (Nasdaq: SANM) is a leading integrated manufacturing solutions provider serving the fastest-growing segments of the global Electronics Manufacturing Services (EMS) market....
Sr Compliance Analyst - Testing
- Coppell, TX (23 miles from Prosper, TX)
- 45+ days ago
- Coppell, TX (23 miles from Prosper, TX)
- 45+ days ago
Qualifications: 4+ years of professional work experience in consumer regulatory compliance, internal audit, compliance testing, or risk management Bachelor's degree....
Demographic Data for Prosper, TX
Moving to Prosper, TX? Find some basic demographic data about Prosper, TX below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Prosper, TX
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Prosper, TX 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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