Regulatory Affairs Specialist Jobs in Lake Forest, 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.
Regulatory Compliance Specialist
- Irvine, CA (10 miles from Lake Forest, CA)
- moments ago
- Irvine, CA (10 miles from Lake Forest, CA)
- moments ago
The District: Irvine Ranch Water District (IRWD) is a progressive, values-driven agency, with an international reputation for its leading-edge financial management practices, water recycling...
Regulatory Affairs Specialist, Sr.
- Irvine, CA (10 miles from Lake Forest, CA)
- 1 day ago
- Irvine, CA (10 miles from Lake Forest, CA)
- 1 day ago
Regulatory Affairs Specialist, Sr....
. + Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout...
Lake Forest : J55 ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: No MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive...
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Regulatory Affairs Specialist I
- Irvine, CA (10 miles from Lake Forest, CA)
- 4 days ago
- Irvine, CA (10 miles from Lake Forest, CA)
- 4 days ago
For further information about the E-Verify program, please click here: click here Job Summary In this high profile role, the Regulatory Affairs Specialist I will be an integral part of an expanding...
Title: Regulatory Affairs Specialist II - Temporary
- Irvine, CA (10 miles from Lake Forest, CA)
- 12 days ago
- Irvine, CA (10 miles from Lake Forest, CA)
- 12 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...
Senior Specialist, Regulatory Affairs - BD Advanced Patient Monitoring
- Laguna Beach, CA (5 miles from Lake Forest, CA)
- 13 days ago
- Laguna Beach, CA (5 miles from Lake Forest, CA)
- 13 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 (10 miles from Lake Forest, CA)
- 13 days ago
- Irvine, CA (10 miles from Lake Forest, CA)
- 13 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...
Compliance Analyst - Provider Compliance
- Orange, CA (15 miles from Lake Forest, CA)
- 21 days ago
- Orange, CA (15 miles from Lake Forest, CA)
- 21 days ago
Provides support with Internal Audit Department activities relating to provider compliance....
Associate Labeling Specialist Regulatory Affairs
- Rancho Santa Margarita, CA (6 miles from Lake Forest, CA)
- 22 days ago
- Rancho Santa Margarita, CA (6 miles from Lake Forest, CA)
- 22 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 (10 miles from Lake Forest, CA)
- 22 days ago
- Irvine, CA (10 miles from Lake Forest, CA)
- 22 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
- 24 days ago
- Lake Forest, CA
- 24 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 (10 miles from Lake Forest, CA)
- 25 days ago
- Irvine, CA (10 miles from Lake Forest, CA)
- 25 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...
- Irvine, CA (10 miles from Lake Forest, CA)
- 30+ days ago
- Irvine, CA (10 miles from Lake Forest, CA)
- 30+ 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....
Risk and Compliance Analyst University of California Irvine
- Irvine, CA (10 miles from Lake Forest, CA)
- 30+ days ago
- Irvine, CA (10 miles from Lake Forest, CA)
- 30+ 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 Lake Forest, CA
Moving to Lake Forest, CA? Find some basic demographic data about Lake Forest, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Lake Forest, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Lake Forest, 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
- Internal Control
- Reimbursement
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- Validation
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Microsoft Visio
- Resolution
- Microsoft SharePoint
- Product Development
- Risk Management
- Engineering
- Strategy Development
- Process Improvement
- Military Background
- Implementation
- Auditing
- Analytical Skills
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Data Analysis
- Collaboration
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Reporting
- Microsoft PowerPoint
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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