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.
Key Responsibilities: Maintain compliance with ISO 9001, MDSAP (ISO 13485, TG(MD)R Sch3, RDC ANVISA 665/2022, CMDR, MHLW 169, FDA 21 CFR 820), EU MDR (2017/745), MDD (93/42/EEC), CA-RHB, NRC, BIS, DOT...
Principal Scientist (Director) - Regulatory Affairs-CMC
- Sacramento, CA
- 8 days ago
- Sacramento, CA
- 8 days ago
**Director, Combination Product Regulatory CMC - (R5)** This Principal Scientist position is equivalent to a Director position. Under direction from the Combination Product Regulatory CMC Team...
Director of Regulatory Affairs ONSITE in Westlake Village, CA Caldera Medical's Mission - To Improve the Quality of Life for Women!...
Summary of Job Responsibilities The Associate Director of Regulatory Affairs will provide regulatory support for medical device systems within infusion technologies....
Provides regulatory impact assessments for changes managed in the quality systems and participates in technical risk assessment exercises....
Director, Regulatory Affairs is the ranking Regulatory Affairs leader for the Dispensing RA organization under the Medication Management Business Unit....
Senior Regulatory Affairs Manager APAC - Diabetes Care (on-site)
- Alameda, CA
- 13 days ago
- Alameda, CA
- 13 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...
Senior Manager, Regulatory Affairs - Device (Onsite or Remote)
- Irvine, CA
- 17 days ago
- Irvine, CA
- 17 days ago
Understanding of device/combination product regulations [21 CFR Parts 3, 4, GCP, GLP, 210/211, 820 QSR (Design Control), European Medical Device Directives and Regulation (MDR/IVDR), ISO 13485, MDSAP...
Associate Director Regulatory Affairs - APAC - Diabetes Care
- Alameda, CA
- 17 days ago
- Alameda, CA
- 17 days ago
The Opportunity This Associate Director Regulatory Affairs - APAC will work on-site at our Alameda, CA, location in the Diabetes Division....
FDA regulations, CLIA requirements, EU IVDR, ISO 13485, and other global regulatory standards relevant to IVDs. RAC certification preferred (U.S., Global, or EU)....
regulations, including 21 CFR 1271 and 21 CFR 312 **Job Location** This role is located onsite in our Eden Prairie, MN (Miromatrix) location with the option for a remote candidate with monthly travel...
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....
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: 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
- 26 days ago
- San Diego, CA
- 26 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...
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
- Molecular Biology
- Biochemistry
- Data Management
- Process Development
- Biology
- Immunology
- Hazardous Materials
- Scientific Writing
- Drug Development
- Gene Therapy
- ICH GCP
- Quality Systems
- Quality Management Systems
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- Quality Management
- GxP
- Electrical Engineering
- Control Systems
- Microbiology
- Document Control
- Inspections
- Medical Device Sales
- FDA Regulations
- Research and Development
- Diagnostic
- Product Development
- Affirmative Action
- Engineering
- Strategy Development
- Quality Assurance
- Auditing
- Implementation
- Written Communication
- Employee Development
- Mentoring
- Collaboration
- Documentation
- Reporting
- Coaching
- Regulations
- Bachelor's Degree
- Policy Development
- English
- Project Management
- Problem Solving
- Team Building
- 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 »