Regulatory Affairs Specialist Jobs in Coto De Caza, CA
- Advantage Technical
- Irvine, CA (13 miles from Coto De Caza, CA)
- 23 hours ago
- Irvine, CA (13 miles from Coto De Caza, CA)
- 23 hours ago
Job Title: Regulatory Affairs Specialist II Location: Hybrid Core onsite days are Tuesday and Thursday; third onsite day is flexible Duration: 1 Year Contract - possible extension Pay Range: $45$50/...
In PersonSenior Compliance Analyst (Hybrid): 25-00196 in Newport Beach
- Energy Jobline ZR
- Newport Beach, CA (16 miles from Coto De Caza, CA)
- 1 day ago
- Newport Beach, CA (16 miles from Coto De Caza, CA)
- 1 day 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...
HybridISO 9001 Quality Assurance & Compliance Specialist
- Lake Elsinore, CA (8 miles from Coto De Caza, CA)
- 6 days ago
- Lake Elsinore, CA (8 miles from Coto De Caza, CA)
- 6 days ago
Overview: Join a dynamic manufacturing team as an ISO 9001 Quality Assurance & Compliance Specialist, where your expertise in quality systems, audits, and documentation will drive operational excellence...
In PersonRemote Mortgage Compliance Analyst
- Paramount Residential Mortgage Group
- Corona, CA (16 miles from Coto De Caza, CA)
- 10 days ago
- Corona, CA (16 miles from Coto De Caza, CA)
- 10 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...
RemotePromo / Ad Specialist ( Regulatory Affairs )
- HCLTech
- Irvine, CA (13 miles from Coto De Caza, CA)
- 10 days ago
- Irvine, CA (13 miles from Coto De Caza, CA)
- 10 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 PersonIT Compliance Analyst (Temporary up to 90 days)
- Banc of California
- Santa Ana, CA (19 miles from Coto De Caza, CA)
- 11 days ago
- Santa Ana, CA (19 miles from Coto De Caza, CA)
- 11 days 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...
In Person Temporary- Pacific Life Insurance Company
- Newport Beach, CA (16 miles from Coto De Caza, CA)
- 11 days ago
- Newport Beach, CA (16 miles from Coto De Caza, CA)
- 11 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 (4 miles from Coto De Caza, CA)
- 11 days ago
- San Juan Capistrano, CA (4 miles from Coto De Caza, CA)
- 11 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 (13 miles from Coto De Caza, CA)
- 11 days ago
- Irvine, CA (13 miles from Coto De Caza, CA)
- 11 days ago
Essential Functions : Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies....
In PersonSenior Specialist, Regulatory Affairs THV
- Edwards Lifesciences Corp
- Irvine, CA (13 miles from Coto De Caza, CA)
- 15 days ago
- Irvine, CA (13 miles from Coto De Caza, CA)
- 15 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....
In PersonRegulatory Affairs Specialist, Sr.
- Prismatik
- Irvine, CA (13 miles from Coto De Caza, CA)
- 18 days ago
- Irvine, CA (13 miles from Coto De Caza, CA)
- 18 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 (13 miles from Coto De Caza, CA)
- 22 days ago
- Irvine, CA (13 miles from Coto De Caza, CA)
- 22 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 TemporaryRegulatory Affairs Specialist I
- Masimo
- Irvine, CA (13 miles from Coto De Caza, CA)
- 30+ days ago
- Irvine, CA (13 miles from Coto De Caza, CA)
- 30+ 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...
In PersonRegulatory Affairs Specialist III - Urology
- Boston Scientific
- Irvine, CA (13 miles from Coto De Caza, CA)
- 30+ days ago
- Irvine, CA (13 miles from Coto De Caza, CA)
- 30+ 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....
HybridRegulatory Affairs Specialist II
- Masimo
- Irvine, CA (13 miles from Coto De Caza, CA)
- 30+ days ago
- Irvine, CA (13 miles from Coto De Caza, CA)
- 30+ 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....
In PersonDemographic Data for Coto De Caza, CA
Moving to Coto De Caza, CA? Find some basic demographic data about Coto De Caza, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Coto De Caza, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Coto De Caza, 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
- Audit Support
- 21 CFR 820
- ISO 13485
- Quality Systems
- Internal Control
- Medical Device Sales
- Validation
- Microsoft Visio
- FDA Regulations
- Corrective Actions & Preventive Actions
- Resolution
- Root Cause Analysis
- Microsoft SharePoint
- Continuous Improvement
- Standard Operating Procedures
- Product Development
- Reimbursement
- Risk Management
- Engineering
- Implementation
- Military Background
- Analytical Skills
- Written Communication
- Auditing
- Process Improvement
- Microsoft Outlook
- Documentation
- Verbal Communication
- Data Analysis
- Collaboration
- Investigation
- Reporting
- Regulations
- Bachelor's Degree
- Policy Development
- Microsoft PowerPoint
- Filing
- Education Experience
- Research Skills
- Project Management
- Time Management
- Microsoft Office
- Sales
- Staff Supervision
- Microsoft Excel
- Problem Solving
- Scheduling
- Leadership
- Communication Skills
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