Regulatory Affairs Specialist Jobs in Frisco, 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.
RandD Regulatory Affairs Associate Principal Scientist - 388730
- Plano, TX (11 miles from Frisco, TX)
- 1 day ago
- Plano, TX (11 miles from Frisco, TX)
- 1 day ago
Overview PepsiCo is a global food and beverage leader operating in more than 200 countries and territories with a product portfolio that includes 22 world-famous, billion-dollar brands. From...
Marketing & Advertising Compliance Analyst
- Plano, TX (11 miles from Frisco, TX)
- 7 days ago
- Plano, TX (11 miles from Frisco, TX)
- 7 days ago
Position Summary: Responsible for ensuring that loanDepot's marketing activities align with relevant laws, regulations, and internal policies and procedures. This role will review marketing...
- Carrollton, TX (16 miles from Frisco, TX)
- 10 days ago
- Carrollton, TX (16 miles from Frisco, TX)
- 10 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 (17 miles from Frisco, TX)
- 30+ days ago
- Coppell, TX (17 miles from Frisco, TX)
- 30+ days ago
Qualifications: 4+ years of professional work experience in consumer regulatory compliance, internal audit, compliance testing, or risk management Bachelor's degree....
Senior Specialist, Regulatory Affairs and Compliance
- Allen, TX (15 miles from Frisco, TX)
- 45+ days ago
- Allen, TX (15 miles from Frisco, TX)
- 45+ days ago
Manages of executes a timely and effective internal audit program. Reviews processes for compliance to appropriate regulations and internal procedures....
Demographic Data for Frisco, TX
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Frisco, TX
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Frisco, TX offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Corrective Actions & Preventive Actions
- Medical Device Sales
- Business Processes
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Product Development
- Affirmative Action
- Engineering
- Risk Management
- Military Background
- Analytical Skills
- Implementation
- Auditing
- Investigation
- Verbal Communication
- Writing Skills
- Data Analysis
- Written Communication
- Collaboration
- Documentation
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Sales
- Microsoft Excel
- Microsoft Word
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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