Manager of Regulatory Affairs Jobs in Valencia, CA
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.
PLEASE NOTE: Must be legally authorized to work in the United States for any employer without sponsorship. For immediate consideration, please apply. Kelly Science & Clinical is seeking a hybrid...
- Santa Clarita, CA (2 miles from Valencia, CA)
- 5 days ago
- Santa Clarita, CA (2 miles from Valencia, CA)
- 5 days ago
PLEASE NOTE: Must be legally authorized to work in the United States for any employer without sponsorship. For immediate consideration, please apply. Kelly Science & Clinical is seeking a hybrid...
Quality Management System (QMS): Oversee the implementation and maintenance of the QMS, ensuring compliance with ISO 13485, FDA 21 CFR Part 820, and other relevant standards....
Director, Regulatory Affairs - Regulatory Operations and North America
- Santa Clarita, CA (2 miles from Valencia, CA)
- 30+ days ago
- Santa Clarita, CA (2 miles from Valencia, CA)
- 30+ days ago
Valencia (CA), United States Director, Regulatory Affairs - Regulatory Operations and North America 155803 Who we are In a life without sound, our work provides meaning. As a leading provider of...
Director, Regulatory Affairs - Regulatory Operations and North America Job Details Sonova AG
- Valencia, CA
- 30+ days ago
- Valencia, CA
- 30+ days ago
Who we are In a life without sound, our work provides meaning. As a leading provider of innovative hearing care solutions, we are not just a company that makes products: we are a team on a mission...
Regulatory Affairs Manager (Santa Clarita, CA)
- Santa Clarita, CA (2 miles from Valencia, CA)
- 60+ days ago
- Santa Clarita, CA (2 miles from Valencia, CA)
- 60+ days ago
Effectively track and communicate compliance plans with HS/Business Leadership. Ensures the QA/RA organizations fully understand the requirements of all regulatory requirements for the company....
Demographic Data for Valencia, CA
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Salary for Manager of Regulatory Affairs Jobs in Valencia, CA
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager of Regulatory Affairss in Valencia, CA 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
- Bioinformatics
- Biology
- Immunology
- Medical Writing
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Biomarkers
- Internal Audits
- Quality Management Systems
- Quality Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- Good Clinical Practice
- Microbiology
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Risk Management
- Strategy Development
- Quality Assurance
- Process Improvement
- Implementation
- Auditing
- Written Communication
- Verbal Communication
- Strategic Planning
- Documentation
- Mentoring
- Collaboration
- Reporting
- Education Experience
- Interpersonal Skills
- Coaching
- Bachelor's Degree
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Teamwork
- Staff Supervision
- Organization
- Research Skills
- Leadership
- Communication Skills
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