1,849 regulatory jobs at 696 companies in San Jose, CA
1w
Save
Mark Applied
Hide
1w
Regulatory Operations Manager
Palo Alto, California, United States
$130k-$179k/yrHybridFull Time
Siemens HealthineersFrankfurt Stock Exchange: SHL: Provides medical imaging and diagnostic solutions to healthcare providers.
5+ YOEBachelor’s degree in biomedical engineering, regulatory, business, or related field; 5+ years in medical device regulatory operations; cross-functional leadership; project management; and global regulatory requirements knowledge.
Regulatory systems, Regulatory ticket system, Dashboards, Reporting tools, Centralized systems, FDA QMSR (21 CFR Part 820), ISO 13485, EU MDR (Regulation (EU) 2017/745), Canadian Medical Devices Regulations (SOR/98-282), MDSAP, CAPA, UDI
Siemens HealthineersFrankfurt Stock Exchange: SHL: Manufactures medical imaging and laboratory diagnostic equipment.
5+ YOEBachelor's degree in biomedical engineering, regulatory, business, or related field; 5+ years in medical device regulatory operations; cross-functional leadership, process improvement, project management, and global regulatory expertise.
regulatory systems, dashboards, reporting tools, ticket system, UDI, FDA QMSR, 21 CFR Part 820, ISO 13485, EU MDR, Canadian Medical Devices Regulations, MDSAP, Microsoft Excel
Pattern Energy: Develops and operates renewable energy and transmission infrastructure.
7+ YOEJD and U.S. bar,7+ years energy regulatory experience,expertise in FERC/NERC/RTOs/ISOs,ability to advise on interconnection, tariffs, compliance, and commercial arrangements.
Mainspring Energy: Manufactures fuel-flexible linear generators for onsite power generation.
15+ YOE15+ years of legal experience, including environmental, energy, utility, or regulatory law; active U.S. state bar membership, environmental permitting and energy regulation knowledge, and strong business judgment.
U.S. EPA, NERC, Inflation Reduction Act, ITC, FEOC
Ambrosia Energy: Building vertically integrated, high-speed solar and battery power plants
Bachelor's degree and regulatory/permitting experience; preferred 4+ years in permitting/regulatory affairs or project development for solar, wind, or battery storage; ERCOT/Texas experience a plus.
Meter: Builds and operates full-stack enterprise networking infrastructure.
J.D. and top law firm experience preferred; in-house regulatory experience; member in good standing of at least one state bar; experience with telecom/ISP regulation, FCPA, export controls, sanctions, privacy (GDPR/CCPA), FCC/safety, and employment/OSHA matters.
Rivian and Volkswagen Group Technologies: A joint venture developing software-defined vehicle technologies and ensuring regulatory compliance for global markets.
8+ YOEBachelor's in engineering or computer science, minimum 8 years in automotive certification/homologation, domain expertise in regulatory areas, familiarity with WVTA/US self-certification and requirements tools, ability to author DVPs and manage regulatory evidence.
New York City or Boston or San Francisco or Salt Lake City or Milton Park or Montréal or London
$208k-$281k/yrRemoteFull Time
RecursionNASDAQ: RXRX: Developing medicines using an AI-native drug discovery platform.
10+ YOE10+ years pharma experience with 8+ years in global regulatory affairs; experience with major health authorities and regulatory submissions; strong regulatory strategy, communication, and cross-functional collaboration skills.
Dispatch Bio: Develops universal immunotherapy treatments for solid tumor cancers.
2+ YOEBachelor’s in life sciences; 2+ years Regulatory Affairs in biotech/pharma; oncology/IND experience; strong communication; regulatory submissions; FDA/ICH knowledge.
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.
San Francisco or Edina or Los Angeles or Philadelphia or Tampa or Denver or Seattle or New York City or Chicago
$105k-$193k/yrHybridFull Time
Marsh McLennanNYSE: MRSH: Provides global insurance brokerage, risk management, and professional consulting services.
3+ YOE3+ years insurance regulatory/filing experience (P&C) with California filings, ability to prepare regulator-ready materials, strong project management and communication, bachelor\u0002s or equivalent experience.
Lam ResearchNASDAQ: LRCX: Manufacturing equipment used to fabricate advanced semiconductor microchips.
10+ YOERequires a JD, U.S. bar licensure, and 10–15 years of progressive legal experience, including 8 years in regulatory counseling and experience with product compliance, supply chains, and corporate compliance.
legal research tools, contract management platforms, compliance management systems
San Mateo or New York City or Boston or Salt Lake City
HybridFull Time
Overjet: AI platform for dental diagnostics and practice management.
7+ YOERequires 7+ years in medical device regulatory affairs, 2+ years with FDA software as a medical device, global submissions experience, regulatory framework expertise, and a scientific or engineering bachelor's degree.
FDA 510(k), De Novo, Health Canada Medical Device License (MDL), EU MDR, UK MHRA, Australian TGA, 21 CFR Part 820, Software as a Medical Device (SaMD), ISO 13485, ISO 14971, IEC 62304, ISO 27001, HIPAA, GDPR
Lam ResearchNASDAQ: LRCX: Designs and manufactures wafer fabrication equipment for the semiconductor industry.
10+ YOERequires a JD, U.S. bar admission, and 10–15 years of progressive legal experience, including 8 years in regulatory counseling involving product compliance, sustainability, supply chains, and government contracting.
legal research tools, contract management platforms, compliance management systems
AccuScan Sciences: Develops liquid biopsy and whole-genome sequencing for cancer diagnostics.
8+ YOEBachelor's degree or higher in a relevant life sciences or regulatory field, 8+ years of IVD regulatory experience, CE-IVDR submission leadership, technical file experience, Notified Body experience, and oncology diagnostics expertise.
EU IVDR (2017/746), ISO 13485, Whole Genome Sequencing (WGS), NGS, DHF, SOPs, US FDA
CytokineticsNASDAQ: CYTK: Develops muscle-directed medicines for cardiovascular and neuromuscular diseases.
7+ YOE10+ years of drug development, 7+ years in regulatory affairs; biotech/pharma; cardiovascular focus; Bachelor's required; advanced degree preferred; strong global regulatory and eCTD experience.
Retro Biosciences: Developing therapies to extend healthy human lifespan.
7+ YOE7+ years hands-on regulatory CMC experience, experience leading CMC strategy for cell therapies, IND/CTA experience, ability to prepare CMC dossiers and lead health-authority interactions; life sciences degree preferred.
Vice President, Regulatory and Head of Regulatory Affairs
San Mateo, California, United States
$340k-$370k/yrOnsiteFull Time
Sagimet BiosciencesNasdaq: SGMT: Develops oral FASN inhibitor drugs for metabolic and inflammatory diseases.
15+ YOEAdvanced degree in scientific or regulatory field; minimum 15 years regulatory affairs experience in biotech/pharma; proven IND, NDA/BLA submissions; strong US and international regulatory expertise.
Verily: Developing data-driven technologies for clinical research and precision health.
5+ YOEBachelors in a quantitative field and 5+ years regulatory affairs experience in medical device/digital health; expertise in SaMD/AI/ML compliance, FDA guidance, ISO 13485, risk management, and statistical evaluation; proficiency with Jira, GitHub, and Google Workspace.
Jira, GitHub, Google Workspace, document control systems, Python, R, Claude, ChatGPT