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.
Senior Privacy & Compliance Analyst
- Los Alamitos, CA (18 miles from Irvine, CA)
- 1 day ago
- Los Alamitos, CA (18 miles from Irvine, CA)
- 1 day ago
Epson is a global technology leader whose philosophy of efficient, compact, and precise innovation enriches lives and helps create a better world. The company is focused on solving societal issues...
Remote Work- Lake Forest, CA (10 miles from Irvine, CA)
- 1 day ago
- Lake Forest, CA (10 miles from Irvine, CA)
- 1 day ago
Pay: up to $48/hr on w2 (no C2C or 3rd parties) Job Title: Regulatory Affairs Specialist II Location: Lake Forest, CA (onsite) Work hours: M-F 8am 5pm onsite Job Description: Work with global partners...
Start Date 9/1/2025 End Date 2/28/2026 % Allocation 100% Engagement Type Vendor Sourced Business Days 84.00 Payment Structure Hourly Days per Week 5 Unit Type Hourly Units per Day 8.00 # of...
In this high profile role, the Regulatory Affairs Specialist I will be an integral part of an expanding regulatory affairs team that is responsible for maintaining and documenting our mission critical...
- Newport Beach, CA (11 miles from Irvine, CA)
- 3 days ago
- Newport Beach, CA (11 miles from Irvine, CA)
- 3 days ago
Job Description: Providing for loved ones, planning rewarding retirements, saving enough for whatever lies ahead our policyholders count on us to be there when it matters most. Its a big ask, but...
Accelerate your career. Join the organization that's driving the world's technology and shape the future. Ingram Micro is a leading technology company for the global information technology...
Job Summary Regulatory Affairs Specialist II/III is responsible for obtaining and documenting our mission-critical, domestic regulatory clearances for Masimo's amazing innovative products....
- Foothill Ranch, CA (5 miles from Irvine, CA)
- 7 days ago
- Foothill Ranch, CA (5 miles from Irvine, CA)
- 7 days ago
We are seeking a highly motivated and detail-oriented Compliance Analyst to join our dynamic, fast-growing startup captive finance company specializing in retail installment loans for the...
Regulatory Affairs Specialist II Job Description The Regulatory Affairs Specialist II plays a pivotal role in ensuring that the company's medical devices comply with regulatory requirements throughout...
Regulatory Affairs Coordinator - Hybrid
- Orange, CA (6 miles from Irvine, CA)
- 15 days ago
- Orange, CA (6 miles from Irvine, CA)
- 15 days ago
Regulatory Affairs Coordinator - Hybrid Req ID: 90381 Location: Irvine, California Division: School of Medicine Department: Cancer Center Position Type: Full Time Salary Range Minimum: USD...
Regulatory Affairs Specialist II
- Lake Forest, CA (10 miles from Irvine, CA)
- 16 days ago
- Lake Forest, CA (10 miles from Irvine, CA)
- 16 days ago
Seeking a detail-oriented and collaborative Regulatory Affairs Specialist II to support global registration efforts and ensure compliance with international medical device regulations....
REMOTE Loan Servicing Compliance Analyst, I
- Anaheim, CA (9 miles from Irvine, CA)
- 17 days ago
- Anaheim, CA (9 miles from Irvine, CA)
- 17 days ago
Come join our amazing team and work remote from home! The Loan Servicing Compliance Analyst I will be responsible for the provisioning documentation for various audit and exam documentation. Also...
Remote Work- Newport Beach, CA (11 miles from Irvine, CA)
- 29 days ago
- Newport Beach, CA (11 miles from Irvine, CA)
- 29 days ago
Job Description: Providing for loved ones, planning rewarding retirements, saving enough for whatever lies ahead our policyholders count on us to be there when it matters most. Its a big ask, but...
Remote IT Quality Assurance and Compliance, Analyst
- Anaheim, CA (9 miles from Irvine, CA)
- 30+ days ago
- Anaheim, CA (9 miles from Irvine, CA)
- 30+ days ago
Come join our amazing team and work remote from home! What youll do: Responsible for the timely and accurate response to audit and compliance requests for the enterprise while also ensuring that...
Remote Work, ensuring compliance with FDA regulations, ISO standards, and other regulatory agencies....
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
- Consulting
- Internal Control
- Management Reporting
- Operations Analysis
- Internal Audits
- 21 CFR 820
- ISO 13485
- Corrective Actions & Preventive Actions
- Business Processes
- Medical Device Sales
- FDA Regulations
- Resolution
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Process Improvement
- Auditing
- Military Background
- Implementation
- Analytical Skills
- Investigation
- Written Communication
- Education Experience
- Verbal Communication
- Documentation
- Data Analysis
- Reporting
- Collaboration
- Interpersonal Skills
- Filing
- Microsoft PowerPoint
- Bachelor's Degree
- Policy Development
- Regulations
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Sales
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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