Regulatory Affairs Specialist Jobs in Newport Coast, CA
Sr Regulatory Affairs Specialist - Neuro
- Medtronic Inc.
- Irvine, CA (11 miles from Newport Coast, CA)
- 1 day ago
- Irvine, CA (11 miles from Newport Coast, CA)
- 1 day ago
Careers That Change Lives The Sr Regulatory Affairs Specialist will play a key role in sustaining the current product portfolio....
In PersonSenior Specialist, Regulatory Affairs TMTT
- Edwards Lifesciences
- Irvine, CA (11 miles from Newport Coast, CA)
- 2 days ago
- Irvine, CA (11 miles from Newport Coast, CA)
- 2 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- Advantage Technical
- Irvine, CA (11 miles from Newport Coast, CA)
- 13 days ago
- Irvine, CA (11 miles from Newport Coast, CA)
- 13 days 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
- 14 days ago
- Newport Beach, CA
- 14 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...
HybridRemote Mortgage Compliance Analyst
- Paramount Residential Mortgage Group
- Corona, CA (24 miles from Newport Coast, CA)
- 23 days ago
- Corona, CA (24 miles from Newport Coast, CA)
- 23 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 (11 miles from Newport Coast, CA)
- 23 days ago
- Irvine, CA (11 miles from Newport Coast, CA)
- 23 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
- 23 days ago
- Newport Beach, CA
- 23 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 (16 miles from Newport Coast, CA)
- 23 days ago
- San Juan Capistrano, CA (16 miles from Newport Coast, CA)
- 23 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 (11 miles from Newport Coast, CA)
- 24 days ago
- Irvine, CA (11 miles from Newport Coast, CA)
- 24 days ago
Essential Functions : Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies....
In Person- Envista
- Brea, CA (23 miles from Newport Coast, CA)
- 28 days ago
- Brea, CA (23 miles from Newport Coast, CA)
- 28 days ago
Prepare and maintain regulatory submissions, product and facility registrations, and certifications in accordance with country-specific requirements to support global product approvals....
In PersonRegulatory Affairs Specialist, Sr.
- Prismatik
- Irvine, CA (11 miles from Newport Coast, CA)
- 30+ days ago
- Irvine, CA (11 miles from Newport Coast, 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 (11 miles from Newport Coast, CA)
- 30+ days ago
- Irvine, CA (11 miles from Newport Coast, 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 TemporaryRegulatory Affairs Specialist I
- Masimo
- Irvine, CA (11 miles from Newport Coast, CA)
- 45+ days ago
- Irvine, CA (11 miles from Newport Coast, CA)
- 45+ 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 (11 miles from Newport Coast, CA)
- 45+ days ago
- Irvine, CA (11 miles from Newport Coast, CA)
- 45+ 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 (11 miles from Newport Coast, CA)
- 45+ days ago
- Irvine, CA (11 miles from Newport Coast, CA)
- 45+ 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 Newport Coast, CA
Moving to Newport Coast, CA? Find some basic demographic data about Newport Coast, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Newport Coast, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Newport Coast, 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
- Institutional Review Board
- ICH Guidelines
- 21 CFR 820
- ISO 13485
- Quality Systems
- Document Management
- Medical Device Sales
- Due Diligence
- Corrective Actions & Preventive Actions
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Product Development
- Microsoft SharePoint
- Continuous Improvement
- Technical Writing
- 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
- Quality Assurance
- 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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