Camp Pendleton North • 50 milesRemote · Hybrid · Onsite · Field · All Environments
Camp Pendleton North • 50 milesRemote · Hybrid · Onsite · Field · All Environments
Camp Pendleton North • 50 milesRemote · Hybrid · Onsite · Field · All Environments
Camp Pendleton North • 50 milesRemote · Hybrid · Onsite · Field · All Environments
82 regulatory specialist jobs at 60 companies in Camp Pendleton North, CA
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Regulatory Specialist
San Juan Capistrano, California, United States
$95k-$150k/yr OnsiteFull Time
5+ YOEPrepare and manage environmental permits, ensure regulatory compliance, coordinate agencies, produce technical reports, manage projects and staff; requires applicable environmental/engineering degree and extensive California permitting experience.
Microsoft Word, Microsoft Excel
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Regulatory Specialist
Irvine, California, United States
$75k/yr OnsiteFull Time
2+ YOEBachelor's degree required (Master's preferred),2+ years in higher education compliance/accreditation,knowledge of accreditation standards,project management and documentation skills,Microsoft Office proficiency.
Microsoft Office Suite
1w
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Senior Specialist Regulatory Affairs
Irvine, California, United States
$96k-$160k/yr HybridFull Time
2+ YOEBachelor's degree in engineering, life sciences, regulatory affairs, or related field and 2+ years of regulatory affairs experience. Requires regulatory submissions and compliance experience; RAC and global submissions experience preferred.
1w
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Regulatory Affairs Specialist
Santa Ana, California, United States
$80k-$95k/yr OnsiteFull Time
3+ YOEBachelor's degree preferred; 3+ years of medical device regulatory experience, knowledge of FDA and international requirements, ISO 13485 and FDA 21 CFR Part 820, and strong documentation and communication skills.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, ERP systems, FDA eMDR
3w
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Sr Regulatory Affairs Specialist
San Diego, California, United States
$91k-$152k/yr HybridFull Time
5+ YOEBachelor's degree and 5+ years regulatory experience for software medical devices; knowledge of SaMD/FDA/MDCG guidance, ISO/IEC standards, regulatory submissions, cybersecurity/privacy, and strong regulatory writing and communication skills.
AI/ML
3w
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Regulatory Affairs Specialist
San Diego, California, United States
$72k-$119k/yr HybridFull Time
2+ YOEBachelor’s degree typically required with 2+ years related experience; knowledge of US/international regulatory requirements, medical device software (IEC 62304), labeling, submissions (510(k), Health Canada, EU MDR) and strong technical writing skills.
IEC 62304
3mo
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Senior Regulatory Affairs Specialist
Marlborough or Irvine or Arden Hills or Maple Grove
$89k-$170k/yr HybridFull Time
4+ YOEBachelor’s degree in a scientific or technical discipline, 4+ years of medical-industry regulatory affairs experience, and experience with 510(k), EU MDR, or international regulatory registrations.
Microsoft Office
6d
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Regulatory Affairs Specialist II
Irvine, California, United States
$76k-$122k/yr RemoteFull Time
2+ YOERequires a BS with 2+ years of experience or a PhD/MS, knowledge of US and European regulatory processes, strong communication skills, teamwork, and English proficiency; medical device regulatory experience preferred.
Research and Development (R&D), 510(k), IDE, PMA, HDE, EU MDR, ISO 13485
6d
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Regulatory Affairs Specialist II
Irvine, California, United States
$76k-$122k/yr RemoteFull Time
2+ YOERequires a BS with 2+ years of experience or a PhD/MS, knowledge of US and European regulatory processes, strong communication skills, teamwork, and English proficiency. Medical device regulatory experience preferred.
Research and Development (R&D), 510(k), IDE, PMA, HDE, ISO 13485
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Regulatory Affairs Specialist, Sr.
Irvine, California, United States
$85k-$120k/yr OnsiteFull Time
5+ YOE5+ years regulatory affairs experience, experience with FDA 510(k)/PMA and international registrations, SOP and audit experience, strong analytical and communication skills.
Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Microsoft Outlook
2w
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Senior Regulatory Affairs Specialist
Irvine or Marlborough or Arden Hills or Maple Grove
$89k-$170k/yr HybridFull Time
4+ YOEBachelor's degree in a scientific, technical, or related discipline and 4+ years of medical industry regulatory affairs experience, including 510(k), EU MDR, or international registrations.
Microsoft Office, 510(k), EU MDR, PMA
1w
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Sr. Specialist, Regulatory Strategy
San Diego, California, United States
$103k-$141k/yr OnsiteFull Time
4+ YOERequires a BS/BA with 4+ years, master's with 2+ years, or JD, PharmD, or PhD. Requires FDA and ICH regulatory knowledge, strong analytical, communication, project management, and computer skills.
Smartsheet
2d
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Junior Regulatory Affairs Specialist
Irvine, California, United States
OnsiteFull Time
1+ YOEBachelor of Science and 1+ year of quality experience in medical device manufacturing. Requires ISO 13485 and 21 CFR QSR/cGMP knowledge, technical writing, regulatory research, and Microsoft Office proficiency.
Microsoft Word, Microsoft Excel, Microsoft Access, ERP, 21 CFR Quality System Regulations, ISO 13485, Medical Device Single Audit Program (MDSAP), EU MDR, UK MDR, RoHS, REACH, Prop 65, CAFDB, USFDA, Health Canada, OSHA, DTSC, OC Health, EPA, 510K, CE Marking
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Senior Regulatory Affairs Specialist - Onsite
Irvine, California, United States
$92k-$138k/yr OnsiteFull Time
4+ YOEBachelor's degree in science or engineering with 4+ years of medical device regulatory experience, or advanced degree with 2+ years. Requires FDA submissions experience; RAC and global regulatory experience preferred.
Investigational Device Exemption (IDE), Premarket Approval (PMA), 510(k), European Union Medical Device Regulation (EU MDR), ISO 13485, ISO 14971, CE Mark
1mo
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Sr Regulatory Affairs Specialist
Irvine, California, United States
$85k-$110k/yr OnsiteFull Time
3+ YOE3+ years medical device regulatory experience (Class II/III), expert knowledge of FDA and international regulations, ISO 13485 and FDA/GMP experience, 510(k) submissions, MS Office proficiency, bachelor\u0002s degree preferred.
Microsoft Word, Microsoft Excel, Microsoft Access, Microsoft Outlook
1w
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Senior Regulatory Affairs Specialist - Onsite
Irvine, California, United States
$92k-$138k/yr OnsiteFull Time
4+ YOEBachelor's degree in science or engineering with 4+ years of medical device regulatory experience, or advanced degree with 2+ years. Requires FDA submission experience; RAC, EU MDR, ISO 13485, and ISO 14971 knowledge preferred.
Investigational Device Exemption (IDE), Premarket Approval (PMA), 510(k), European Union Medical Device Regulation (EU MDR), ISO 13485, ISO 14971
2mo
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Regulatory Affairs Specialist - Vascular (on-site)
Santa Clara or Temecula
$82k-$141k/yr OnsiteFull Time
2+ YOEBachelor's degree (or equivalent), 2+ years in a regulated industry, strong regulatory knowledge for medical devices, submission experience, teamwork and communication skills.
Electronic Document Management Systems (EDMS), Product Lifecycle Management (PLM)
2mo
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Regulatory Affairs Specialist - Vascular (on-site)
Santa Clara or Temecula
$82k-$141k/yr OnsiteFull Time
2+ YOEBachelor's degree or equivalent, 2+ years in a regulated industry, knowledge of medical device regulations, strong written/verbal communication, and experience preparing regulatory submissions.
EDMS, PLM, Microsoft Excel
1mo
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Senior Specialist, Regulatory Affairs THV
Irvine, California, United States
$92k-$130k/yr OnsiteFull Time
5+ YOEBachelor's degree (or equivalent), minimum 5 years related experience, experience preparing domestic and international medical device submissions, knowledge of global regulations for Class II/III devices.
4d
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Sr. Regulatory Affairs Spec
Santa Ana, California, United States
$106k-$120k/yr OnsiteFull Time
3+ YOEBachelor's degree, regulatory affairs certificate, and 3–5 years of quality assurance and regulatory experience in medical devices or pharmaceuticals. Requires GMP, CFR, USP, ISO 13485, risk management, FMEA, validation, and English proficiency.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Adobe Acrobat, GMP, CFR, USP, ISO 13485, Failure Mode Effects Analysis (FMEA), CAPA
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