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.
- Newport Beach, CA (11 miles from Irvine, CA)
- 4 days ago
- Newport Beach, CA (11 miles from Irvine, CA)
- 4 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...
Compliance Analyst - Provider Compliance
- Orange, CA (6 miles from Irvine, CA)
- 7 days ago
- Orange, CA (6 miles from Irvine, CA)
- 7 days ago
Provides support with Internal Audit Department activities relating to provider compliance....
Associate Labeling Specialist Regulatory Affairs
- Rancho Santa Margarita, CA (11 miles from Irvine, CA)
- 8 days ago
- Rancho Santa Margarita, CA (11 miles from Irvine, CA)
- 8 days ago
Demonstrate a strong understanding of Applied Medical Quality Management System and effectively troubleshoot challenges or obstacles that may affect project timelines....
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...
Senior Regulatory Affairs Specialist, Digital Health / Software Products
- Lake Forest, CA (10 miles from Irvine, CA)
- 10 days ago
- Lake Forest, CA (10 miles from Irvine, CA)
- 10 days ago
As a Senior Regulatory Affairs Specialist within Alcon's Digital Health Quality and Regulatory Affairs (QRA) team, you will be trusted to ensure compliance with regulatory requirements for software...
Senior Compliance Analyst Description POSITION DESCRIPTION: EnFin is a financial services company that provides financing for residential solar PV and energy efficiency upgrades, backed by the PV...
Compliance & Regulatory Affairs Specialist
- Diamond Bar, CA (17 miles from Irvine, CA)
- 11 days ago
- Diamond Bar, CA (17 miles from Irvine, CA)
- 11 days ago
Compliance & Regulatory Affairs Specialist Corporate position responsible for ensuring artwork and advertisements are legally compliant for all of Niagara, LLC....
- Anaheim, CA (13 miles from Irvine, CA)
- 13 days ago
- Anaheim, CA (13 miles from Irvine, CA)
- 13 days ago
This position will provide on-going support to management, conduct regulatory research, assist with health plan audits and internal audits....
Senior Regulatory Affairs Specialist - BD Advanced Patient Monitoring
- Laguna Beach, CA (14 miles from Irvine, CA)
- 18 days ago
- Laguna Beach, CA (14 miles from Irvine, CA)
- 18 days ago
Regulatory Affairs Specialist** you will support the execution of RA functions for new product development product line in critical care. Ensure compliance to global processes and regulations....
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....
Risk and Compliance Analyst University of California Irvine
- Irvine, CA
- 21 days ago
- Irvine, CA
- 21 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....
Assists in liaising with Internal Audit membersto ensure appropriate controls over IT design while assisting the IT GRCManager with the IT Director and cross-functional members to facilitateoperational...
Regulatory Compliance Specialist
- Brea, CA (14 miles from Irvine, CA)
- 24 days ago
- Brea, CA (14 miles from Irvine, CA)
- 24 days ago
Employment Type: Salaried Work Arrangement: Remote Position Summary: We are seeking a Regulatory Compliance Specialist to join our team of food regulatory professionals, to provide expertise in...
- Pomona, CA (17 miles from Irvine, CA)
- 30+ days ago
- Pomona, CA (17 miles from Irvine, CA)
- 30+ days ago
" The Compliance Analyst, Junior position supports the Client Compliance group and assists in the adherence of client contractual and legal requirements, as well regulatory compliance as required...
- Orange, CA (6 miles from Irvine, CA)
- 60+ days ago
- Orange, CA (6 miles from Irvine, CA)
- 60+ 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....
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
- Finance
- Medicaid
- Flexibility
- Call Center Experience
- Medicare
- Internal Control
- Management Reporting
- Fraud Investigation
- Reimbursement
- Institutional Review Board
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Microsoft Visio
- Root Cause Analysis
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Implementation
- Military Background
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Data Analysis
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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