633 regulatory manager jobs at 267 companies in Capitola, CA
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Regulatory Operations Manager
Palo Alto, California, United States
$130k-$179k/yr HybridFull Time
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
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Manager, Regulatory Response
Mountain View or New York City or Washington
$211k-$293k/yr OnsiteFull Time
10+ YOE1+ MgmtBachelor's degree or equivalent practical experience, 10 years in program or project management, and 1 year of people management; regulatory response, litigation, or AI experience preferred.
AI tools
3d
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Regulatory Readiness Program Manager
Menlo Park or Seattle or Menlo Park or Seattle
$134k-$192k/yr OnsiteFull Time
5+ YOERequires 5+ years in strategy, operations, consulting, or program management; 2+ years in product environments and regulatory, risk, compliance, audit, controls, or information security work.
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Manager, Regulatory Affairs
Pleasanton, California, United States
$150k-$180k/yr HybridFull Time
5+ YOEBachelor’s degree and 5+ years of medical device regulatory experience required, including FDA and international submissions, 510(k), post-market compliance, project management, and technical writing.
FDA Electronic Submission Gateway (ESG), WebTrader, 510(k), Medical Device Reporting (MDR), EU MDR, PSUR
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Regulatory Compliance Program Manager, Regulatory Delivery & Transparency - Trust and Safety
San Jose, California, United States
$109k-$288k/yr OnsiteFull Time
5+ YOEProven program management delivering complex cross-functional regulatory programs; deep knowledge of DSA/Online Safety Acts and global regulations; strong risk assessment, stakeholder management, and communication skills; flexible for global collaboration.
3w
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Autonomous Vehicle Regulatory Program Manager (GPSSC)
Warren or Sunnyvale
$160k-$291k/yr HybridFull Time
7+ YOEBachelor's degree,7+ years program management or regulatory compliance experience in safety-critical technical environments,strong regulatory knowledge for autonomous vehicles,program planning,stakeholder coordination,and executive communication skills.
Goal Structuring Notation (GSN)
2mo
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Sr. Manager, Regulatory Affairs
San Carlos, California, United States
$183k-$194k/yr RemoteFull Time
9+ YOEDevelop and execute global regulatory CMC strategies, prepare and file CMC submissions, manage Health Authority interactions; BSc in a scientific discipline and 9+ years vaccine/biotech experience; experience with module 32S/32P and CMC DS sections (BLA/IND/IMPD).
LIMS, SAP, TrackWise, Veeva
3mo
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Regulatory Affairs Manager – Diabetes Care (on-site)
Alameda or Milpitas or Austin
$114k-$228k/yr OnsiteFull Time
4+ YOELead US regulatory strategy for new products and lifecycle; manage team; ensure regulatory success and compliance.
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Manager, Regulatory Affairs CMC
Foster City, California, United States
$147k-$190k/yr OnsiteFull Time
4+ YOEBachelor’s degree in Life Sciences, Chemistry, Pharmacy, or related discipline; 4–6+ years in pharmaceutical project, CMC development, or CMC Regulatory Affairs; Regulatory Affairs Certification a plus.
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Staff Regulatory Engineer
Palo Alto, California, United States
$186k-$233k/yr HybridFull Time
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.
Jama, Codebeamer, Flow, Python, CAPL
2w
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Director, Regulatory
Menlo Park, California, United States
$233k-$275k/yr RemoteFull Time
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
4w
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Regulatory Affairs Manager – Heart Failure (on-site)
Pleasanton, California, United States
$114k-$228k/yr OnsiteFull Time
6+ YOEBachelor's in technical discipline or equivalent, minimum 6 years regulatory experience, experience with 510(k)/IDE/PMA and US/EU regulations, strong communication, ability to lead submissions and manage complex projects.
3mo
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Executive Director, Regulatory Affairs CMC
Redwood City, California, United States
OnsiteFull Time
15+ YOE5+ Mgmt15+ years Regulatory CMC experience; leadership; BS/MS/PhD in science or healthcare; experience with US/EU/Japan/Canada regulatory filings; BLA filing experience; 5+ years of management.
Regulatory Affairs, CMC, Biopharma, GxP, IND, BLA, CTA, MAA
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Head of Regulatory
San Mateo or New York City or Boston or Salt Lake City
HybridFull Time
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
2w
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Senior Regulatory Affairs Specialist
Sunnyvale, California, United States
$129k-$218k/yr HybridFull Time
8+ YOERequires 8+ years of medical device regulatory affairs experience, knowledge of US, Canadian, and EU regulations, regulatory submissions, design controls, risk management, and a bachelor's degree or higher.
da Vinci, Ion, U.S. FDA 510(k), Health Canada, EU MDR, Letters to File, pre-submissions
3mo
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Vice President, Regulatory and Head of Regulatory Affairs
San Mateo, California, United States
$340k-$370k/yr OnsiteFull Time
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.
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Regulatory Compliance Director
Carlsbad or Irvine or Milpitas or Richmond
$170k-$250k/yr HybridFull Time
8+ YOE1+ Mgmt8+ years leading regulatory compliance in consumer electronics; governance, cross-functional collaboration, international travel.
BOMs, ECR/ECO/MCO, GCF, PTCRB, Carrier Certifications
1mo
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Director - Quality Management & Regulatory Affairs
Palo Alto, California, United States
$89-$118/hr OnsiteFull Time
5+ YOEMaster's degree required; 5+ years progressive experience with senior leadership; knowledge of accreditation/regulatory standards; leadership, project management, and EHR/Microsoft Office proficiency.
Electronic Health Records (EHR), Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Visio
5d
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Sr Director, Regulatory Affairs
Redwood City, California, United States
OnsiteFull Time
15+ YOEBS/MS required, advanced degree desirable, and 15+ years of biopharmaceutical regulatory affairs experience, including biologics, BLA submissions, commercial launch, global health authority interactions, and personnel management.
IND, CTA, BLA, MAA, FDA, EMA, PMDA, CMC, MLR, PRC
3mo
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Senior Regulatory Affairs Specialist
San Jose, California, United States
$149k-$175k/yr OnsiteFull Time
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.
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