86 regulatory specialist jobs at 50 companies in Tracy, CA
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Regulatory Affairs Specialist
Pleasanton, California, United States
$74k-$116k/yrOnsiteFull Time
AbbottNYSE: ABT: Provides medical devices, diagnostics, and science-based nutritional products.
Bachelor's degree or equivalent, ability to support product registration and regulatory submissions, knowledge of regulatory requirements and GxP, strong communication and attention to detail.
AbbottNYSE: ABT: Manufactures medical devices, diagnostics, and nutritional health products.
Bachelor's or equivalent in technical discipline, knowledge of regulatory submissions and GxP, strong communication, attention to detail, ability to work in a matrixed environment.
IntuitiveNASDAQ: ISRG: Robotic-assisted systems for minimally invasive surgery.
8+ YOE8+ years regulatory affairs experience, bachelor’s degree or equivalent, expertise in global regulatory requirements, project leadership, technical documentation, agency negotiation, and audits/submissions.
Thermo Fisher ScientificNYSE: TMO: Sells equipment and chemicals for scientific research and healthcare.
2+ YOEBachelor's degree plus 2 years regulatory experience (or advanced degree), knowledge of FDA/EU IVDR/MDR, ISO 13485/GMP/MDSAP, regulatory submissions, change control, post-market surveillance, and strong communication and project skills.
4+ YOEBachelor's in a scientific discipline, 6 years regulatory submissions experience with BS (or 4 years with MS), knowledge of FDA and international device regulations (21 CFR 820, ISO 13485, EU MDR), ability to lead regulatory strategy and prepare submissions.
CloroxNew York Stock Exchange: CLX: Manufactures and markets consumer cleaning and wellness products.
4+ YOEBachelor's in a technical field,4+ years FDA foods regulatory CPG experience,knowledge of US and Canadian food regulations,labeling/claims/ingredients expertise,third-party certification experience,and strong cross-functional communication.
The Surplus Line Association of California: Oversees California's surplus lines insurance marketplace and ensures compliance.
California resident with a bachelor's degree; experience researching/interpreting laws or insurance compliance; strong written/verbal/presentation skills; Microsoft Office proficiency; member education and problem-solving experience.
Microsoft Outlook, Microsoft Word, Microsoft Excel, Microsoft PowerPoint
The Surplus Line Association of California: Oversees compliance and data reporting for California's surplus lines insurance.
California residency and a related bachelor's degree required. Requires substantive research, complex regulatory analysis, excellent writing and communication, critical thinking, project management, and Microsoft Office proficiency.
Microsoft Outlook, Microsoft Word, Microsoft Excel, Microsoft PowerPoint
Senior Regulatory Affairs Specialist - Pleasanton, CA
Pleasanton, California, United States
$145k-$160k/yrHybridFull Time
Calyxo: Develops vacuum-assisted devices for minimally invasive kidney stone removal
5+ YOEMaster's +5 years or Bachelor's +8 years in medical device/pharma/biotech/IVD with FDA experience, 510(k) submissions, regulatory strategy for Class II/III devices, eQMS experience, strong writing and cross-functional collaboration.
Stanford University: A private research university providing higher education and research.
3+ YOEBachelor's degree and 3 years of related experience or equivalent combination. Requires clinical trials operations, regulatory affairs, IRB, FDA regulations, Good Clinical Practice, MS Office, databases, communication, and writing skills.
Sr. Regulatory Affairs Specialist , Medical Devices Operational Compliance Center (MD-OCC)
Sunnyvale, California, United States
$171k-$231k/yrOnsiteFull Time
AmazonNASDAQ: AMZN: Global online retail and cloud computing technology provider.
7+ YOE7+ years working with engineering teams, 5+ years technical product/program management, experience with regulatory filings (FDA/21 CFR 820, ISO13485, MDD/IVD), Class II/III devices, bachelor's in scientific discipline, strong analytical and communication skills.
State Controller's Office: California's fiscal controller managing state financial operations and assets.
Requires eligibility for California state service classification; experience managing complex health programs or projects, including planning, analysis, policy, regulations, standards, budgeting, and resource management.
GeneFab: Specialized contract manufacturing for advanced cell and gene therapies.
10+ YOEBachelor's degree preferred in science, 10+ years in compliance, quality, and CDMO/CMO management, 10+ years GMP/QA experience, and knowledge of FDA, EMA, ICH, and international biopharma regulations.
Accreditation, Regulatory, and Licensing Specialist IV, DHCS FSR Program (KFHP/H)
Pleasanton or Oakland
$154k-$199k/yrOnsiteFull Time
Kaiser Permanente: Provides integrated medical care and health insurance plans.
5+ YOEBachelor's degree plus 5 years of healthcare operations, quality, risk, or hospital experience, or 8 years equivalent. Requires 1 year leadership, 2 years database/spreadsheet experience, and California clinical licensure or MCQMD certification.
Sustainability Reporting Specialist, Global Regulatory Disclosure
Cupertino, California, United States
OnsiteFull Time
AppleNASDAQ: AAPL: Designs and sells consumer electronics, software, and online services.
Experienced leader in sustainability and financial reporting, internal controls, and data management; improving data collection systems, managing project timelines, and crafting report narratives.
Compliance Specialist (Power Resources Specialist I/II) - Energy Department
San Jose, California, United States
$108k-$143k/yrHybridFull Time
City of San José: Provides governance, public safety, and infrastructure for San José.
0+ YOEBachelor's degree in an analytical field, ability to draft California energy compliance reports, map and manage regulatory requirements, and communicate technical information; Power Resources Specialist II requires 1 year of related experience.
Principal Consultant, Biologist/Regulatory Specialist, Power and Renewables
Walnut Creek or Sacramento
$111k-$161k/yrHybridFull Time
ERM: Provides sustainability, environmental, and risk management consulting services.
6+ YOEBS/MS in biology, environmental science, or related field; 6+ years of consulting experience in California energy markets; CEQA/NEPA, permitting, regulatory, leadership, and client development expertise.
StrykerNYSE: SYK: Manufactures medical devices and equipment for healthcare providers.
Repair medical devices according to approved procedures, quality standards, regulatory requirements, and production goals; work independently and collaborate cross-functionally.