Regulatory Affairs Specialist Jobs in Dana Point, CA
Promo / Ad Specialist ( Regulatory Affairs )
- Irvine, CA (20 miles from Dana Point, CA)
- 9 hours ago
- Irvine, CA (20 miles from Dana Point, CA)
- 9 hours 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...
IT Compliance Analyst (Temporary up to 90 days)
- Santa Ana, CA (22 miles from Dana Point, CA)
- 13 hours ago
- Santa Ana, CA (22 miles from Dana Point, CA)
- 13 hours ago
BANC OF CALIFORNIA AND YOUR CAREER Banc of California, Inc. (NYSE: BANC) is a bank holding company headquartered in Los Angeles with one wholly-owned banking subsidiary, Banc of California (the...
- Newport Beach, CA (13 miles from Dana Point, CA)
- 14 hours ago
- Newport Beach, CA (13 miles from Dana Point, CA)
- 14 hours 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...
Senior Specialist, Regulatory Affairs
- San Juan Capistrano, CA (10 miles from Dana Point, CA)
- 15 hours ago
- San Juan Capistrano, CA (10 miles from Dana Point, CA)
- 15 hours 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...
- Irvine, CA (20 miles from Dana Point, CA)
- 1 day ago
- Irvine, CA (20 miles from Dana Point, CA)
- 1 day ago
Essential Functions : Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies....
Senior Specialist, Regulatory Affairs THV
- Irvine, CA (20 miles from Dana Point, CA)
- 5 days ago
- Irvine, CA (20 miles from Dana Point, CA)
- 5 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....
Regulatory Affairs Specialist, Sr.
- Irvine, CA (20 miles from Dana Point, CA)
- 7 days ago
- Irvine, CA (20 miles from Dana Point, CA)
- 7 days ago
Essential Functions : Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies....
Regulatory Affairs Specialist II - Temporary
- Irvine, CA (20 miles from Dana Point, CA)
- 12 days ago
- Irvine, CA (20 miles from Dana Point, 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...
Regulatory Affairs Specialist I
- Irvine, CA (20 miles from Dana Point, CA)
- 23 days ago
- Irvine, CA (20 miles from Dana Point, CA)
- 23 days ago
Job Summary 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...
Regulatory Affairs Specialist III - Urology
- Irvine, CA (20 miles from Dana Point, CA)
- 23 days ago
- Irvine, CA (20 miles from Dana Point, CA)
- 23 days ago
We are looking to hire an enthusiastic individual for a Regulatory Affairs Specialist III position supporting our rapidly growing active implantable device portfolio....
Regulatory Affairs Specialist II
- Irvine, CA (20 miles from Dana Point, CA)
- 23 days ago
- Irvine, CA (20 miles from Dana Point, CA)
- 23 days ago
Job Summary Regulatory Affairs Specialist II/III is responsible for obtaining and documenting our mission-critical, domestic regulatory clearances for Masimos amazing innovative products....
- Costa Mesa, CA (20 miles from Dana Point, CA)
- 28 days ago
- Costa Mesa, CA (20 miles from Dana Point, CA)
- 28 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...
Regulatory Affairs Specialist - SAP
- Irvine, CA (20 miles from Dana Point, CA)
- 29 days ago
- Irvine, CA (20 miles from Dana Point, CA)
- 29 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...
Compliance Analyst - Retirement (Remote)
- Aliso Viejo, CA (9 miles from Dana Point, CA)
- 30+ days ago
- Aliso Viejo, CA (9 miles from Dana Point, CA)
- 30+ days ago
Who We Are: NFP, an Aon company, is a multiple Best Places to Work award winner in Business Insurance. We are an organization of consultative advisors and problem solvers. We help companies and...
Remote Work2026 Summer Intern - Legal & Compliance Analyst
- Newport Beach, CA (13 miles from Dana Point, CA)
- 45+ days ago
- Newport Beach, CA (13 miles from Dana Point, CA)
- 45+ 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+...
Demographic Data for Dana Point, CA
Moving to Dana Point, CA? Find some basic demographic data about Dana Point, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Dana Point, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Dana Point, CA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Internal Audits
- ICH Guidelines
- 21 CFR 820
- Institutional Review Board
- ISO 13485
- Quality Systems
- Quality Management Systems
- Validation
- Medical Device Sales
- Microsoft Visio
- FDA Regulations
- Corrective Actions & Preventive Actions
- Root Cause Analysis
- Continuous Improvement
- Standard Operating Procedures
- Product Development
- Strategy Development
- Reimbursement
- Risk Management
- Engineering
- Military Background
- Analytical Skills
- Written Communication
- Implementation
- Auditing
- Process Improvement
- Microsoft Outlook
- Documentation
- Verbal Communication
- Collaboration
- Interpersonal Skills
- Investigation
- Reporting
- Bachelor's Degree
- Policy Development
- Microsoft PowerPoint
- Regulations
- Filing
- Education Experience
- Project Management
- Time Management
- Research Skills
- Microsoft Office
- Computer Skills
- Staff Supervision
- Microsoft Excel
- Problem Solving
- Scheduling
- Leadership
- Communication Skills
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