Regulatory Affairs Specialist Jobs in Fullerton, 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.
- Los Angeles, CA (21 miles from Fullerton, CA)
- 2 days ago
- Los Angeles, CA (21 miles from Fullerton, CA)
- 2 days ago
Research Compliance Analyst 2880534 One of the most prestigious and well-known universities seeks a Research Compliance Analyst. The successful candidate will be responsible for staffing,...
Compliance Analyst - Community Reinvestment Act
- Los Angeles, CA (21 miles from Fullerton, CA)
- 3 days ago
- Los Angeles, CA (21 miles from Fullerton, CA)
- 3 days ago
Kforce has a client that is seeking a Compliance Analyst - Community Reinvestment Act in Los Angeles, CA. Summary:The CRA Compliance Analyst is responsible for supporting the Company's compliance...
Title: Regulatory Affairs Specialist II - Temporary
- Irvine, CA (12 miles from Fullerton, CA)
- 3 days ago
- Irvine, CA (12 miles from Fullerton, CA)
- 3 days ago
Support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact all Bio-Rad products currently CE Marked under the IVD Directive. Activities include preparation...
- Los Angeles, CA (21 miles from Fullerton, CA)
- 3 days ago
- Los Angeles, CA (21 miles from Fullerton, CA)
- 3 days ago
Research Compliance Analyst Location: Hybrid - 10945 Le Conte Ave, Suite 3360 Los Angeles, CA 90024 Duration: 6 month contract Required Experience: Bachelors Degree with 2+ years of Clinical...
Senior Specialist, Regulatory Affairs - BD Advanced Patient Monitoring
- Laguna Beach, CA (23 miles from Fullerton, CA)
- 4 days ago
- Laguna Beach, CA (23 miles from Fullerton, CA)
- 4 days ago
Becton Dickinson (BD) recently completed the acquisition of the Edwards Critical Care business. This position is part of the Critical Care division, and as such will become a part of the BD...
Marketing & Advertising Compliance Analyst
- Irvine, CA (12 miles from Fullerton, CA)
- 4 days ago
- Irvine, CA (12 miles from Fullerton, CA)
- 4 days ago
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...
Contractual Compliance Analyst
- Los Angeles, CA (21 miles from Fullerton, CA)
- 10 days ago
- Los Angeles, CA (21 miles from Fullerton, CA)
- 10 days ago
Job Summary: The Contractual Compliance Analyst (Analyst) is responsible for conducting in-depth investigations and enforcement actions related to the Registrar Accreditation Agreement, Registry...
Compliance Analyst - Provider Compliance
- Orange, CA (6 miles from Fullerton, CA)
- 12 days ago
- Orange, CA (6 miles from Fullerton, CA)
- 12 days ago
Provides support with Internal Audit Department activities relating to provider compliance....
Associate Labeling Specialist Regulatory Affairs
- Rancho Santa Margarita, CA (23 miles from Fullerton, CA)
- 12 days ago
- Rancho Santa Margarita, CA (23 miles from Fullerton, CA)
- 12 days ago
Demonstrate a strong understanding of Applied Medical Quality Management System and effectively troubleshoot challenges or obstacles that may affect project timelines....
Specialist, Regulatory Affairs TMTT
- Irvine, CA (12 miles from Fullerton, CA)
- 13 days ago
- Irvine, CA (12 miles from Fullerton, CA)
- 13 days ago
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 (22 miles from Fullerton, CA)
- 15 days ago
- Lake Forest, CA (22 miles from Fullerton, CA)
- 15 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...
- Irvine, CA (12 miles from Fullerton, CA)
- 16 days ago
- Irvine, CA (12 miles from Fullerton, CA)
- 16 days ago
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 (9 miles from Fullerton, CA)
- 16 days ago
- Diamond Bar, CA (9 miles from Fullerton, CA)
- 16 days ago
Compliance & Regulatory Affairs Specialist Corporate position responsible for ensuring artwork and advertisements are legally compliant for all of Niagara, LLC....
- Long Beach, CA (21 miles from Fullerton, CA)
- 17 days ago
- Long Beach, CA (21 miles from Fullerton, CA)
- 17 days ago
Position Summary The Property Compliance Analyst will complete a variety of assignments related to tenant file compliance with Section 42, Section 8 or other Government Housing Programs with a...
Senior Regulatory Affairs Specialist - BD Advanced Patient Monitoring
- Laguna Beach, CA (23 miles from Fullerton, CA)
- 23 days ago
- Laguna Beach, CA (23 miles from Fullerton, CA)
- 23 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....
Demographic Data for Fullerton, CA
Moving to Fullerton, CA? Find some basic demographic data about Fullerton, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Fullerton, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Fullerton, 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
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Data Analysis
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Sales
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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