Regulatory Affairs Specialist Jobs in Capistrano Beach, CA
- Actalent
- Irvine, CA (20 miles from Capistrano Beach, CA)
- 4 days ago
- Irvine, CA (20 miles from Capistrano Beach, CA)
- 4 days ago
Job Title: Regulatory Affairs Specialist II Job Description A Regulatory Affairs Specialist II plays a pivotal role in ensuring that the company's medical devices comply with regulatory requirements...
In PersonSenior Specialist, Regulatory Affairs (bilingual Mandarin Chinese)
- Becton, Dickinson and Company
- Irvine, CA (20 miles from Capistrano Beach, CA)
- 7 days ago
- Irvine, CA (20 miles from Capistrano Beach, CA)
- 7 days ago
This position involves supporting regulatory submissions, maintaining product compliance, and providing regulatory guidance to cross-functional teams for our China regional market....
In PersonRegulatory Affairs Coordinator
- Kelly Science, Engineering, Technology & Telecom
- Irvine, CA (20 miles from Capistrano Beach, CA)
- 9 days ago
- Irvine, CA (20 miles from Capistrano Beach, CA)
- 9 days ago
Management Systems (e.g....
In PersonSpecialist, Regulatory Affairs TMTT
- Edwards Lifesciences
- Irvine, CA (20 miles from Capistrano Beach, CA)
- 13 days ago
- Irvine, CA (20 miles from Capistrano Beach, CA)
- 13 days ago
Track timelines and documents milestone achievements for inclusion in regulatory submissions....
In PersonSenior Regulatory Compliance Specialist
- Irvine Ranch Water District
- Irvine, CA (20 miles from Capistrano Beach, CA)
- 20 days ago
- Irvine, CA (20 miles from Capistrano Beach, CA)
- 20 days ago
Senior Regulatory Compliance Specialist This listing closes on 11/24/2025 at 11:59 PM Pacific Time (US & Canada); Tijuana. Employer Irvine Ranch Water District Salary $45.70 - $68.32 Hourly...
In Person- Planet Pharmahttps://cdn.haleymarketing.com/templates/63514/logos/square.pnghttps://www.planet-pharma.comhttps://www.planet-pharma.com
- Irvine, CA (20 miles from Capistrano Beach, CA)
- 24 days ago
- Irvine, CA (20 miles from Capistrano Beach, CA)
- 24 days ago
HM's Top Needs: 1. EU Labeling Requirements 2. Global labeling requirements, 21 CFR 801, EU MDR Regulation, ISO15223, ISO20417 3. Project Management and Change Management skills Education...
In PersonRegulatory Affairs Specialist - SAP
- Insight Global
- Irvine, CA (20 miles from Capistrano Beach, CA)
- 26 days ago
- Irvine, CA (20 miles from Capistrano Beach, CA)
- 26 days ago
NA We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action...
In PersonSenior Specialist, Regulatory Affairs TMTT
- Edwards Lifesciences
- Irvine, CA (20 miles from Capistrano Beach, CA)
- 30+ days ago
- Irvine, CA (20 miles from Capistrano Beach, CA)
- 30+ days ago
Track timelines and documents milestone achievements for inclusion in regulatory submissions. May interact with regulatory agencies as part of submission review and on-site audit support....
Hybrid- Pacific Life Insurance Company
- Newport Beach, CA (13 miles from Capistrano Beach, CA)
- 45+ days ago
- Newport Beach, CA (13 miles from Capistrano Beach, CA)
- 45+ 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...
In PersonSenior Specialist, Regulatory Affairs
- Quest Diagnostics
- San Juan Capistrano, CA (10 miles from Capistrano Beach, CA)
- 45+ days ago
- San Juan Capistrano, CA (10 miles from Capistrano Beach, CA)
- 45+ days ago
Manage submissions such as US FDA Section 510(k) Notifications, Pre-market Approval (PMA) Applications and Supplements, EU IVDR, Technical Documentation, ROW submissions and global product registrations...
In PersonRegulatory Affairs Specialist II - Temporary
- Bio-Rad Laboratories
- Irvine, CA (20 miles from Capistrano Beach, CA)
- 60+ days ago
- Irvine, CA (20 miles from Capistrano Beach, CA)
- 60+ 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...
In Person Temporary- ANDURIL INDUSTRIES
- Costa Mesa, CA (20 miles from Capistrano Beach, CA)
- 60+ days ago
- Costa Mesa, CA (20 miles from Capistrano Beach, CA)
- 60+ days ago
Anduril Industries is a defense technology company with a mission to transform U.S. and allied military capabilities with advanced technology. By bringing the expertise, technology, and business...
In Person2026 Summer Intern - Legal & Compliance Analyst
- Pacific Investment Management Company, LLC
- Newport Beach, CA (13 miles from Capistrano Beach, CA)
- 90+ days ago
- Newport Beach, CA (13 miles from Capistrano Beach, CA)
- 90+ days ago
PIMCO is a global leader in active fixed income. With our launch in 1971 in Newport Beach, California, PIMCO introduced investors to a total return approach to fixed income investing. In the 50+...
In PersonSenior Regulatory Affairs Specialist - Urology
- Boston Scientific
- Irvine, CA (20 miles from Capistrano Beach, CA)
- 90+ days ago
- Irvine, CA (20 miles from Capistrano Beach, CA)
- 90+ days ago
The Senior Regulatory Affairs Specialist is responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process and sustaining engineering projects...
HybridDemographic Data for Capistrano Beach, CA
Moving to Capistrano Beach, CA? Find some basic demographic data about Capistrano Beach, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Capistrano Beach, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Capistrano Beach, CA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Annuities
- 21 CFR 820
- Internal Audits
- ISO 13485
- Change Control
- Validation
- Document Management
- Medical Device Sales
- Corrective Actions & Preventive Actions
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Product Development
- Continuous Improvement
- Microsoft SharePoint
- Technical Writing
- Reimbursement
- Strategy Development
- Engineering
- Risk Management
- Analytical Skills
- Implementation
- Written Communication
- Auditing
- Military Background
- Collaboration
- Process Improvement
- Documentation
- Verbal Communication
- Data Analysis
- Investigation
- Reporting
- Education Experience
- Bachelor's Degree
- Policy Development
- Microsoft PowerPoint
- Filing
- Project Management
- Research Skills
- Sales
- Regulations
- Microsoft Office
- Time Management
- Staff Supervision
- Microsoft Excel
- Customer Service
- Problem Solving
- Scheduling
- Leadership
- Communication Skills
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