Director of Regulatory Affairs Jobs in Santa Clarita, CA
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.
- Valencia, CA (2 miles from Santa Clarita, CA)
- 5 days ago
- Valencia, CA (2 miles from Santa Clarita, CA)
- 5 days ago
Kelly Science & Clinical is seeking a hybrid Director, Regulatory Affairs for a direct hire position at a leading client in Valencia, CA....
Kelly Science & Clinical is seeking a hybrid Director, Regulatory Affairs for a direct hire position at a leading client in Valencia, CA....
Quality Management - Regulatory Affairs
- Valencia, CA (2 miles from Santa Clarita, CA)
- 10 days ago
- Valencia, CA (2 miles from Santa Clarita, CA)
- 10 days ago
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
- 30+ days ago
- Santa Clarita, CA
- 30+ days ago
Director, Regulatory Affairs - Regulatory Operations and North America (Hybrid / Onsite) As the Director, Regulatory Affairs - Regulatory Operations and North America for Advanced Bionics, you will...
Director, Regulatory Affairs - Regulatory Operations and North America Job Details Sonova AG
- Valencia, CA (2 miles from Santa Clarita, CA)
- 30+ days ago
- Valencia, CA (2 miles from Santa Clarita, CA)
- 30+ days ago
Director, Regulatory Affairs - Regulatory Operations and North America (Hybrid / Onsite) As the Director, Regulatory Affairs - Regulatory Operations and North America for Advanced Bionics, you will...
Regulatory Affairs Manager (Santa Clarita, CA)
- Santa Clarita, CA
- 60+ days ago
- Santa Clarita, 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....
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Salary for Director of Regulatory Affairs Jobs in Santa Clarita, CA
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
Highest Education Level
Director of Regulatory Affairss in Santa Clarita, CA 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
- 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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