105 regulatory affairs jobs at 59 companies in Irvine, CA
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Regulatory Affairs Manager
Santa Ana, California, United States
$38-$48/hr OnsitePart Time
5+ YOEBachelor's in a scientific field, 5+ years regulatory affairs experience in dietary supplements/botanicals/TCM, PCQI required, HACCP preferred, audit and FDA regulatory experience.
2d
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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.
4w
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Regulatory Affairs Associate
Long Beach, California, United States
$35-$40/hr OnsiteContract
3+ YOEBachelor's degree required (life sciences or chemistry preferred),3+ years regulatory affairs experience,proficiency with Microsoft Office,strong organizational and time-management skills.
Microsoft Office
1w
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Regulatory Affairs Specialist
Burbank, California, United States
$75k-$85k/yr RemoteFull Time
2+ YOERequires 2–3 years of dietary supplement regulatory affairs experience, claims and label review experience, FDA/FTC knowledge, DSHEA and 21 CFR Part 111 familiarity, and a relevant bachelor's degree.
Claude, Notion AI, Amazon
2mo
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Manager, Regulatory Affairs
California or Los Angeles or Los Angeles County or San Francisco or Philadelphia or United States
$113k-$154k/yr OnsiteFull Time
5+ YOEBachelor's degree in a relevant field and 5–7+ years regulatory affairs experience in cosmetics/personal care; strong knowledge of global cosmetic and packaging regulations; experience with global launches and submissions; cross-functional influence and mentoring skills.
1mo
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Regulatory Affairs Specialist
Torrance, California, United States
OnsiteFull Time
3+ YOE3+ years medical device experience with ≥1 year in regulatory affairs; BA/S in science/engineering or equivalent; RA certification (RAC) a plus; knowledge of global regulations, QSR820, ISO 13485, IVDR; strong communication and analytical skills.
e-MDR, MDSAP
2mo
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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
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Regulatory Affairs Specialist II
Brea, California, United States
$86k-$105k/yr HybridFull Time
2+ YOEBachelor's degree, 2+ years regulatory affairs experience in medical devices (or Master's +1 year). Strong EU MDR knowledge (CER, SSCP, PSUR, PMS). Experience with international submissions and regulatory strategy.
Microsoft Office
1mo
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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
1w
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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
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Regulatory Affairs Officer
Pasadena, California, United States
$128k-$150k/yr HybridFull Time
7+ YOE7+ years legal or compliance experience, 5+ years financial industry experience, fixed-income knowledge, regulatory rulemaking expertise, strong analytical, organizational, and communication skills.
3mo
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Regulatory Affairs Coordinator
Orange or Irvine
$36-$59/hr OnsiteFull Time
3+ YOEExperience submitting IRB applications; 3-5 years RAC or assistant RAC; strong English communication; regulatory knowledge; ability to manage multiple tasks and maintain confidentiality.
OnCore, Microsoft Office, Zoom
1mo
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Senior Specialist, Regulatory Affairs (THV)
Irvine, California, United States
$95k/yr OnsiteFull Time
3+ YOE3–5 years medical device regulatory affairs experience, bachelor’s in a scientific discipline, knowledge of global medical device regulations and quality systems, strong writing and communication skills, and ability to manage submissions and adverse event reporting.
Microsoft Office Suite
2w
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Sr Director, Regulatory Affairs Strategy
Irvine, California, United States
$227k-$317k/yr HybridFull Time
15+ YOE15+ years regulatory affairs experience, advanced scientific degree (MD/PhD/PharmD) required; deep US FDA and international regulatory knowledge; leadership, strategic planning, and cross-functional collaboration skills.
2w
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Sr Director, Regulatory Affairs Strategy
Irvine, California, United States
$227k-$317k/yr HybridFull Time
15+ YOE15+ years regulatory affairs experience in US and ex-US environments; doctorate (MD/PhD/PharmD) in a scientific discipline; deep US FDA and international regulatory knowledge; leadership, communication, and project management skills.
4w
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Regulatory Affairs Specialist II
Duarte, California, United States
$41-$63/hr OnsiteFull Time
2+ YOEPrepare and review regulatory submissions, support investigators and manufacturing/QC/QA teams, draft SOPs and protocols; 2+ years regulatory experience with Bachelors (or 0–2 with Masters).
iRIS
2mo
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Senior Regulatory Affairs Associate
Lake Forest, California, United States
$103k-$133k/yr OnsiteFull Time
2+ YOEBachelor's degree or equivalent experience, 2 years relevant experience, 1 year leadership, knowledge of regulatory submissions, GxP/SOP adherence, strong English communication, onsite in Lake Forest, CA.
2mo
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Senior Specialist, Regulatory Affairs
El Segundo, California, United States
$80k-$90k/yr HybridFull Time
3+ YOE3+ years regulatory experience in cosmetics/pharma/consumer goods, Bachelor's in life sciences/pharmacy/chemistry, Mandarin proficiency, Microsoft Office skills, ability to work onsite 60%+ and manage international product registrations.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint
3w
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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
2mo
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Vice President, Medical Affairs, Clinical Operations & Regulatory Affairs
Seal Beach, California, United States
$256k-$294k/yr OnsiteFull Time
15+ YOE10+ MgmtAdvanced scientific degree,15+ years progressive leadership in biotech/pharma,10+ years leading regulatory affairs,clinical operations and medical affairs experience,expert knowledge of FDA/ICH/GCP/GMP,executive leadership skills.
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