Regulatory Affairs Specialist Jobs in Ladera Ranch, CA
- Planet Pharmahttps://cdn.haleymarketing.com/templates/63514/logos/square.pnghttps://www.planet-pharma.comhttps://www.planet-pharma.com
- Irvine, CA (14 miles from Ladera Ranch, CA)
- 2 days ago
- Irvine, CA (14 miles from Ladera Ranch, CA)
- 2 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 PersonRemote Mortgage Encompass Systems Compliance Analyst
- Paramount Residential Mortgage Group
- Corona, CA (22 miles from Ladera Ranch, CA)
- 2 days ago
- Corona, CA (22 miles from Ladera Ranch, CA)
- 2 days ago
Overview PRMG is one of the nations largest privately owned mortgage banks, and has been in business since early 2001. PRMG offers industry leading stability/security. Over 25% of our total...
RemoteRegulatory Affairs Specialist - SAP
- Insight Global
- Irvine, CA (14 miles from Ladera Ranch, CA)
- 4 days ago
- Irvine, CA (14 miles from Ladera Ranch, CA)
- 4 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 PersonSr Regulatory Operations Specialist
- Entegee
- Irvine, CA (14 miles from Ladera Ranch, CA)
- 5 days ago
- Irvine, CA (14 miles from Ladera Ranch, CA)
- 5 days ago
Job Summary: Responsible for managing submission publishing, device listings, UDI data collection, and maintaining regulatory compliance for medical devices in the US and EU markets. Job...
In PersonSr Regulatory Affairs Specialist - Neuro
- Medtronic Inc.
- Irvine, CA (14 miles from Ladera Ranch, CA)
- 8 days ago
- Irvine, CA (14 miles from Ladera Ranch, CA)
- 8 days ago
Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections....
In PersonSenior Specialist, Regulatory Affairs TMTT
- Edwards Lifesciences
- Irvine, CA (14 miles from Ladera Ranch, CA)
- 9 days ago
- Irvine, CA (14 miles from Ladera Ranch, CA)
- 9 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....
HybridSenior Compliance Analyst (Hybrid): 25-00196 in Newport Beach
- Energy Jobline ZR
- Newport Beach, CA (11 miles from Ladera Ranch, CA)
- 21 days ago
- Newport Beach, CA (11 miles from Ladera Ranch, CA)
- 21 days ago
Energy Jobline is the largest and fastest growing global Energy Job Board and Energy Hub. We have an audience reach of over 7 million energy professionals, 400,000+ monthly advertised global...
HybridPromo / Ad Specialist ( Regulatory Affairs )
- HCLTech
- Irvine, CA (14 miles from Ladera Ranch, CA)
- 30+ days ago
- Irvine, CA (14 miles from Ladera Ranch, CA)
- 30+ days ago
(k) and/or IDE and/or PMA devices Product Labeling requirements and standards Technical Writing experience Systems Knowledge such as content management systems, document management, workflow design...
In Person- Pacific Life Insurance Company
- Newport Beach, CA (11 miles from Ladera Ranch, CA)
- 30+ days ago
- Newport Beach, CA (11 miles from Ladera Ranch, CA)
- 30+ 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 (5 miles from Ladera Ranch, CA)
- 30+ days ago
- San Juan Capistrano, CA (5 miles from Ladera Ranch, CA)
- 30+ 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 Person- PRISMATIK DENTALCRAFT, INC.
- Irvine, CA (14 miles from Ladera Ranch, CA)
- 30+ days ago
- Irvine, CA (14 miles from Ladera Ranch, CA)
- 30+ days ago
Essential Functions : Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies....
In PersonRegulatory Affairs Specialist, Sr.
- Prismatik
- Irvine, CA (14 miles from Ladera Ranch, CA)
- 30+ days ago
- Irvine, CA (14 miles from Ladera Ranch, CA)
- 30+ days ago
Essential Functions : Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies....
In PersonRegulatory Affairs Specialist II - Temporary
- Bio-Rad Laboratories
- Irvine, CA (14 miles from Ladera Ranch, CA)
- 30+ days ago
- Irvine, CA (14 miles from Ladera Ranch, CA)
- 30+ 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 (17 miles from Ladera Ranch, CA)
- 45+ days ago
- Costa Mesa, CA (17 miles from Ladera Ranch, CA)
- 45+ 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 (11 miles from Ladera Ranch, CA)
- 60+ days ago
- Newport Beach, CA (11 miles from Ladera Ranch, CA)
- 60+ 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 PersonDemographic Data for Ladera Ranch, CA
Moving to Ladera Ranch, CA? Find some basic demographic data about Ladera Ranch, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Ladera Ranch, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Ladera Ranch, CA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- 21 CFR 820
- Internal Audits
- Institutional Review Board
- ICH Guidelines
- Annuities
- ISO 13485
- Quality Systems
- Document Management
- Medical Device Sales
- Corrective Actions & Preventive Actions
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Product Development
- Microsoft SharePoint
- Continuous Improvement
- Strategy Development
- Reimbursement
- Engineering
- Risk Management
- Implementation
- Analytical Skills
- Auditing
- Written Communication
- Military Background
- Process Improvement
- Documentation
- Verbal Communication
- Data Analysis
- Collaboration
- Interpersonal Skills
- Investigation
- Reporting
- Bachelor's Degree
- Policy Development
- Microsoft PowerPoint
- Filing
- Education Experience
- Project Management
- Research Skills
- Sales
- Regulations
- Microsoft Office
- Time Management
- Staff Supervision
- Microsoft Excel
- Problem Solving
- Scheduling
- Leadership
- Communication Skills
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