Director of Regulatory Affairs Jobs in Dallas, 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.
- Plano, TX (18 miles from Dallas, TX)
- 1 day ago
- Plano, TX (18 miles from Dallas, TX)
- 1 day ago
Aventiv Technologies – Where your future awaits - YouTube Job Purpose: The Director of Regulatory Affairs manages the Company’s interests before state and federal regulatory agencies, industry groups...
PURPOSE AND SCOPE: Ensure overall (other than auditing responsibilities) regulatory compliance for FMCNA pharmaceutical product. Provides regulatory input to facilities in the preparation and...
Remote WorkManager, Regulatory Affairs Americas
- Lewisville, TX (24 miles from Dallas, TX)
- 30+ days ago
- Lewisville, TX (24 miles from Dallas, TX)
- 30+ days ago
Demonstrated experience regarding Quality Management System activities compliant with ISO 13485 and 21 CFR 820. Hard skills Extensive knowledge of ISO 13485 and ISO 14971, and 21 CFR 820....
Demographic Data for Dallas, TX
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Salary for Director of Regulatory Affairs Jobs in Dallas, TX
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
Highest Education Level
Director of Regulatory Affairss in Dallas, TX offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Director of Regulatory Affairs position
- Clinical Research
- Biology
- Immunology
- Oncology
- Assay Development
- Medical Writing
- Drug Development
- Neuroscience
- Clinical Trials
- Drug Discovery
- Biotechnology
- Infectious Disease
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Biomarkers
- Quality Systems
- Quality Management Systems
- 21 CFR 820
- GxP
- ICH Guidelines
- ISO 13485
- Change Control
- Good Laboratory Practice
- Good Clinical Practice
- Microbiology
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Standard Operating Procedures
- Engineering
- Product Development
- Strategy Development
- Quality Assurance
- Implementation
- Military Background
- Auditing
- Mentoring
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- English
- Regulations
- Policy Development
- Project Management
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Leadership
- Communication Skills
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