Manager of Regulatory Affairs Jobs in Lewisville, TX
A Manager of Regulatory Affairs in the quality control industry plays a pivotal role in ensuring that the company's products meet all necessary regulatory standards. Their key responsibilities include developing and implementing regulatory strategies, monitoring changes to regulatory guidelines, and ensuring the organization's compliance with these changes. They also engage in the preparation, review, and submission of regulatory documents to regulatory agencies. To effectively execute these responsibilities, they liaise with various stakeholders within and outside the organization, such as product developers, project managers, and regulatory bodies.
Important skills and certifications for a Manager of Regulatory Affairs include strong organizational and project management skills, excellent written and verbal communication skills, as well as a keen eye for detail. Analytical thinking and problem-solving skills are also crucial in this role. Additionally, they should possess relevant certifications such as the Regulatory Affairs Certification (RAC), which is recognized worldwide as the leading credential for regulatory professionals in the healthcare product sector. Before becoming a Manager of Regulatory Affairs, a person may have roles such as a Regulatory Affairs Specialist, Quality Control Analyst, or a Quality Assurance Associate. These roles would provide the necessary exposure and experience in quality control and regulatory affairs needed for the managerial position.
- Plano, TX (22 miles from Lewisville, TX)
- 1 day ago
- Plano, TX (22 miles from Lewisville, TX)
- 1 day ago
Coordinates with and supervises one direct report, Manager of Regulatory Affairs, who manages Regulatory analysts....
Mgr, Regulatory Affairs Pharma - HealthCanada
- Dallas, TX (24 miles from Lewisville, TX)
- 26 days ago
- Dallas, TX (24 miles from Lewisville, TX)
- 26 days ago
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 WorkDemonstrated 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 Lewisville, TX
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Salary for Manager of Regulatory Affairs Jobs in Lewisville, TX
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager of Regulatory Affairss in Lewisville, TX offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Manager 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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