Director of Regulatory Affairs Jobs in California
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.
Regulatory Affairs Manager Heart Failure (on-site)
- Pleasanton, CA
- 45+ days ago
- Pleasanton, CA
- 45+ days ago
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses...
About the role: The Director of Regulatory Affairs leads the Regulatory Affairs team and its strategic initiatives within the fast-evolving food and dietary supplement industry....
Manager, Regulatory Affairs (International Regulations) - Biosense Webster, Inc.
- Irvine, CA
- 21 hours ago
- Irvine, CA
- 21 hours ago
Job title Manager, Regulatory Affairs (International Regulations) - Biosense Webster, Inc. Function Regulatory Affairs Group Sub function Regulatory Affairs Category Manager, Regulatory Affairs...
Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international...
Position Summary We are currently seeking an exceptional leader as Director, Regulatory Affairs, to join our team in the mission to restore vision to patients....
Position Summary: Ultragenyx is seeking a highly motivated Senior Director, Regulatory Affairs CMC, who is a team builder and enjoys a fast-paced, dynamic work environment....
Associate Director, Regulatory Affairs CMC - San Diego, CA
- San Diego, CA
- 3 days ago
- San Diego, CA
- 3 days ago
Mirador is a next-generation precision medicine company focused on immunology and inflammation. The companys Mirador360 TM precision development engine leverages the latest advances in human...
Director, FDA Regulatory Affairs & Food Safety while assuring FDA, other federal, state, and local government and all applicable regulatory compliance for Central products....
Maze Therapeutics is seeking a Director, Regulatory Affairs-CMC to be a key driver of CMC regulatory strategy for our clinical-stage small molecule programs....
The Opportunity: The Associate Director of Regulatory Affairs will provide regulatory leadership to clinical development programs in oncology....
Lead internal/supplier audits and CAPAs; train auditors. Manage document control, sealed source/device registries, and complaint programs....
Kyverna is seeking an experienced and driven Associate Director of Regulatory Affairs to join our regulatory team....
Director, Regulatory Affairs - Job ID: DRA Ascendis Pharma - 4.8 Palo Alto, CA Job Details Full-time $225,000 - $240,000 a year 15 hours ago Benefits Paid parental leave Health savings account AD&D...
Knowledge of compliance with harmonized international standards and regulations relevant to IVD devices such as ISO 13485:2016, ISO 14971:2019, MDSAP Demonstrates strong analytical, critical thinking...
Associate Director Regulatory Affairs CMC Acadia Pharmaceuticals Inc. $160,000-$199,600 United States, California, San Diego 12830 El Camino Real (Show on map) Jun 03, 2025 About Acadia Pharmaceuticals...
Demographic Data for California
Moving to California? Find some basic demographic data about California below.
Director of Regulatory Affairs Online Courses and Training Opportunities
Title Synonyms
Users interested in this job title also searched for the following job title
Salary for Director of Regulatory Affairs Jobs in California
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
Highest Education Level
Director of Regulatory Affairss in California 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
- Biochemistry
- Biology
- Immunology
- Assay Development
- Medical Writing
- Scientific Writing
- Drug Development
- Clinical Trials
- Drug Discovery
- Toxicology
- Biotechnology
- Next-Generation Sequencing
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- ICH GCP
- Internal Audits
- Quality Management Systems
- Quality Systems
- Supplier Auditing
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- GxP
- Change Control
- Medical Device Sales
- Microbiology
- Document Management
- FDA Regulations
- Research and Development
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Process Improvement
- Quality Assurance
- Implementation
- Auditing
- Verbal Communication
- Written Communication
- Mentoring
- Collaboration
- Documentation
- Coaching
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
Other Career Titles
Here are some other career titles that require similar skills
Director of Regulatory Affairs Related Career Advice Articles
Top Skills and Quality Control Training You Need to Get Promoted
Ready to take your quality control career to the next level? Seek out quality control training for these highly desired skills for quality control jobs.
Read article »
Quality Assurance vs. Quality Control: What’s the Difference?
Deciding on a career in QA vs. QC can be tough if you don’t know which is which. Find out the difference between quality control and quality assurance.
Read article »