81 regulatory specialist jobs at 58 companies in Fallbrook, CA

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Senior Regulatory Affairs Specialist
San Diego, California, United States
$91k-$152k/yr HybridFull Time
Dexcom
DexcomNasdaq: DXCM: Manufacturer of continuous glucose monitoring systems for diabetes management.
5+ YOE5+ years regulatory affairs experience for medical devices, proficiency with US and EU device regulations, experience supporting 510(k)/license/technical documentation submissions, strong technical writing and communication.
3w
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Regulatory Specialist
San Juan Capistrano, California, United States
$95k-$150k/yr OnsiteFull Time
ALL4
ALL4: Provides strategic environmental health and safety consulting services.
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
2w
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Regulatory Specialist
Irvine, California, United States
$75k/yr OnsiteFull Time
Westcliff University
Westcliff University: Provides accredited undergraduate, graduate, and doctoral degree programs globally.
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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Regulatory Affairs Specialist
San Diego, California, United States
$72k-$119k/yr HybridFull Time
Dexcom
DexcomNASDAQ: DXCM: Develops continuous glucose monitoring systems for diabetes management.
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
2mo
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Senior Regulatory Affairs Specialist
Marlborough or Irvine or Arden Hills or Maple Grove
$89k-$170k/yr HybridFull Time
Boston Scientific
Boston ScientificNYSE: BSX: Developing and manufacturing innovative medical devices for less-invasive treatments.
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, Sr.
Irvine, California, United States
$85k-$120k/yr OnsiteFull Time
Glidewell
Glidewell: Designs and manufactures custom dental restorations and laboratory products.
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
3d
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Senior Regulatory Affairs Specialist
Irvine or Marlborough or Arden Hills or Maple Grove
$89k-$170k/yr HybridFull Time
Boston Scientific
Boston ScientificNYSE: BSX: Developer and manufacturer of innovative medical devices and therapies.
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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Sr. Regulatory Compliance Specialist
Irvine, California, United States
$63k-$97k/yr RemoteFull Time
Ventura Foods
Ventura Foods: Manufactures custom food solutions for foodservice and retail businesses.
3+ YOE3+ years' regulatory compliance experience in food/beverage/pharmaceutical, knowledge of global food laws, label and ingredient compliance, strong communication and project leadership skills.
Microsoft Office, PIM, Decernis gComply, Decernis gComply Plus, Trustwell/Genesis
2w
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Staff International Regulatory Affairs Specialist
Irvine, California, United States
$110k-$183k/yr HybridFull Time
Stryker
StrykerNYSE: SYK: Manufactures medical devices and equipment for healthcare providers.
4+ YOEBachelor's in engineering, life sciences, regulatory science or related; minimum 4 years regulatory affairs experience in medical device/biotech/pharma; experience with international submissions and interpreting global regulations.
2w
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Sr Regulatory Affairs Specialist
Irvine, California, United States
$85k-$110k/yr OnsiteFull Time
Masimo
MasimoNasdaq: MASI: Develops noninvasive patient monitoring technologies and consumer audio products.
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
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Senior Specialist, Regulatory Strategy
San Diego, California, United States
OnsiteFull Time
Neurocrine Biosciences
Neurocrine BiosciencesNASDAQ: NBIX: Develops pharmaceuticals for neurological, endocrine, and psychiatric disorders.
4+ YOEBS/BA with 4+ years, or MS with 2+ years, or JD/PhD/PharmD with no experience; strong regulatory knowledge, FDA/ICH familiarity, project management, teamwork, and communication.
Smartsheet, Microsoft Excel, Microsoft Word
1mo
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Senior Specialist, Regulatory Affairs (THV)
Irvine, California, United States
$95k/yr OnsiteFull Time
JenaValve Technology
JenaValve Technology: Developing transcatheter heart valve systems for aortic disease treatment.
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
1mo
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Regulatory Affairs Specialist - Vascular (on-site)
Santa Clara or Temecula
$82k-$141k/yr OnsiteFull Time
Abbott
AbbottNYSE: ABT: Manufactures medical devices, diagnostics, and nutritional health products.
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)
1mo
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Regulatory Affairs Specialist - Vascular (on-site)
Santa Clara or Temecula
$82k-$141k/yr OnsiteFull Time
Abbott
AbbottNYSE: ABT: Provides medical devices, diagnostics, and science-based nutritional products.
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
Edwards Lifesciences
Edwards LifesciencesNYSE: EW: Designs and manufactures medical devices for structural heart disease.
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.
1w
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Government Regulatory Compliance Specialist
San Diego, California, United States
$98k-$171k/yr HybridFull Time
General Atomics
General Atomics: Designs and manufactures unmanned aircraft and nuclear technology systems.
10+ YOEBachelor's degree or equivalent experience, ~10 years finance/accounting experience at government contractor preferred, knowledge of FAR and cost accounting, strong analysis, communication, and ERP (SAP) skills.
SAP, Microsoft Office
5d
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Senior Regulatory and Scientific Affairs Specialist (Remote)
Bridgewater or Dallas or Boston or Chicago or San Diego or New Jersey
$85k-$110k/yr RemoteFull Time
Nestlé
NestléSIX Swiss Exchange: NESN: Produces and sells a wide range of food and beverages.
4+ YOEBachelor's degree in food science, nutrition, chemistry, or related science; 4+ years in food or supplement regulatory work; project management, compliance, and problem-solving skills; national travel availability.
SAP, ContentHub, Veeva
3d
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Regulatory & Compliance HC Specialist 4 - Risk Management FT Days
Orange, California, United States
$123k-$238k/yr OnsiteFull Time
University of California, Irvine
University of California, Irvine: Public research university offering higher education and academic degrees.
5+ YOEFive years in hospital quality or regulatory compliance; knowledge of CMS, California regulations, and Joint Commission standards; bachelor's degree in a health-related field, RN, or equivalent experience; strong analytical and communication skills.
CMS, The Joint Commission, California Department of Public Health (CDPH)
1mo
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Associate Specialist – Premarket Regulatory Affairs (Global)
Rancho Santa Margarita, California, United States
$70k-$80k/yr OnsiteFull Time
Applied Medical
Applied Medical: Manufacturer of advanced medical devices and surgical products.
1+ YOE1+ year regulatory affairs or quality assurance experience in medical devices; proficiency interpreting regulations/standards; strong technical writing, communication, and analytical skills; motivated self-starter.
2mo
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Compliance Specialist
Irvine, California, United States
$84k-$85k/yr OnsiteFull Time
Avanath
Avanath: Acquires and manages affordable and workforce apartment communities.
2+ YOE2+ years affordable multi-housing/property management experience, Certified Occupancy Specialist (or similar), familiarity with housing agencies and LIHTC/HUD compliance, strong regulatory interpretation skills, and Yardi Voyager and Microsoft Office proficiency.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Access, Yardi Voyager