Regulatory Affairs Specialist Jobs in Irvine, 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.
Temporary Regulatory Affairs Coordinator Job Description Who We Are Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation's...
Who We Are Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation's top 10 public universities by U.S. News & World Report....
Temporary Clinical Regulatory Affairs Coordinator University of California Irvine
- Irvine, CA
- 3 days ago
- Irvine, CA
- 3 days ago
Who We Are Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation's top 10 public universities by U.S. News & World Report....
Compliance Analyst - Audit & Certifications Apply now SUMMARY We are seeking a detail-oriented and proactive Compliance Analyst to join our growing team. In this role, you will be instrumental in...
A Day in the Life The Sr Regulatory Affairs Specialist will play a key role in sustaining the current product portfolio....
Regulatory Affairs Specialist Contract Type: Contractor Location: Irvine Industry: Pharmaceuticals Contact Name: Flora Pollack Contact Phone: Date Published: 05-Jun-2025 Regulatory Affairs Specialist...
Position Summary: Responsible for ensuring that loanDepot's marketing activities align with relevant laws, regulations, and internal policies and procedures. This role will review marketing...
Regulatory and Compliance Analyst Rivian vision insurance United States, California, Irvine 14600 Myford Road (Show on map) Jun 05, 2025 About Rivian Rivian is on a mission to keep the world...
Senior Regulatory Compliance Specialist
- Corona, CA (13 miles from Irvine, CA)
- 9 days ago
- Corona, CA (13 miles from Irvine, CA)
- 9 days ago
Are you ready to step into a pivotal role as a Senior Regulatory Compliance Specialist for the City of Corona? W here you'll lead complex environmental compliance efforts and ensure adherence to...
Regulatory Affairs and Compliance Analyst (Medicare)
- Orange, CA (6 miles from Irvine, CA)
- 9 days ago
- Orange, CA (6 miles from Irvine, CA)
- 9 days ago
Regulatory Affairs and Compliance Analyst (Medicare) CalOptima CalOptima Health is seeking a highly motivated Regulatory Affairs and Compliance Analyst (Medicare) to join our team. The Regulatory...
Principal Controls & Compliance Analyst (remote)
- Santa Ana, CA (6 miles from Irvine, CA)
- 11 days ago
- Santa Ana, CA (6 miles from Irvine, CA)
- 11 days ago
Principal Controls & Compliance Analyst (remote) First American Financial Corporation - 3.8 Santa Ana, CA Job Details $109,650 - $146,175 a year 11 hours ago Benefits Employee stock purchase plan...
Remote Work- Newport Beach, CA (11 miles from Irvine, CA)
- 11 days ago
- Newport Beach, CA (11 miles from Irvine, CA)
- 11 days ago
Job Description: Pacific Life is investing in bright, agile, and diverse talent to contribute to our mission of innovating our business and creating superior customer experience. We are actively...
Regulatory Affairs Specialist II
- Pomona, CA (17 miles from Irvine, CA)
- 11 days ago
- Pomona, CA (17 miles from Irvine, CA)
- 11 days ago
Regulatory Affairs Specialist II Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life....
- Brea, CA (14 miles from Irvine, CA)
- 12 days ago
- Brea, CA (14 miles from Irvine, CA)
- 12 days ago
Works in partnership with manufacturing and RA/QA in designing and enhancing quality management systems to facilitate overall regulatory compliance....
15345 Barranca Pkwy, Irvine, California 92618Full-time Qualifications Strong communication, customer service, time management and organizational skills. Bachelor's degree or equivalent experience...
Demographic Data for Irvine, CA
Moving to Irvine, CA? Find some basic demographic data about Irvine, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Irvine, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Irvine, 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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