Regulatory Affairs Specialist Jobs in Fairfield, 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.
- Davis, CA (22 miles from Fairfield, CA)
- 2 days ago
- Davis, CA (22 miles from Fairfield, CA)
- 2 days ago
Skills FDA Quality Systems regulations, 21 CFR 820, ISO13485, ISO14971, Regulatory, Regulatory affairs, FDA Additional Skills & Qualifications Ability to define problems, collect data, establish facts...
- Davis, CA (22 miles from Fairfield, CA)
- 18 days ago
- Davis, CA (22 miles from Fairfield, CA)
- 18 days ago
Support internal audits and continuous improvement initiatives. Perform additional duties as assigned....
- Napa, CA (22 miles from Fairfield, CA)
- 30+ days ago
- Napa, CA (22 miles from Fairfield, CA)
- 30+ days ago
ABOUT REDWOOD CREDIT UNION (RCU): At Redwood Credit Union, our mission is to passionately serve the best interests of our Members and communities. Since 1950, we have been dedicated to supporting...
Regulatory Affairs Specialist 1 825405
- Hercules, CA (22 miles from Fairfield, CA)
- 30+ days ago
- Hercules, CA (22 miles from Fairfield, CA)
- 30+ days ago
Understanding of scientific reports, risk management, Quality Systems Let our local Helpmates recruiters help you reach your career goals....
- Napa, CA (22 miles from Fairfield, CA)
- 30+ days ago
- Napa, CA (22 miles from Fairfield, CA)
- 30+ days ago
WHO WE ARE Relation Insurance is a leading, innovative company with a strong commitment to excellence and a passion for delivering cutting-edge solutions to our clients. As a key player in the...
Job Type Full-time Description Westamerica is among the largest commercial banks headquartered in California. We are looking for outstanding people to join our winning team. We reached our current...
- Davis, CA (22 miles from Fairfield, CA)
- 90+ days ago
- Davis, CA (22 miles from Fairfield, CA)
- 90+ days ago
audits and risk assessments, regulatory research and training, and review of policies and procedures....
Demographic Data for Fairfield, CA
Moving to Fairfield, CA? Find some basic demographic data about Fairfield, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Fairfield, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Fairfield, CA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Corrective Actions & Preventive Actions
- Medical Device Sales
- Business Processes
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Product Development
- Affirmative Action
- Engineering
- Risk Management
- Military Background
- Analytical Skills
- Implementation
- Auditing
- Investigation
- Verbal Communication
- Writing Skills
- Data Analysis
- Written Communication
- Collaboration
- Documentation
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Sales
- Microsoft Excel
- Microsoft Word
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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