659 regulatory manager jobs at 272 companies in Soquel, CA
3d
Save
Mark Applied
Hide
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; 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
3d
Save
Mark Applied
Hide
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
1d
Save
Mark Applied
Hide
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
2w
Save
Mark Applied
Hide
Regulatory Affairs Manager
Gaithersburg or South San Francisco or Santa Clara or Cambridge
$109k-$164k/yr OnsiteFull Time
3+ YOEBachelor's in a scientific/regulatory discipline, 3+ years regulatory experience in biopharma or health authority, strong project management and leadership skills, knowledge of drug development, excellent communication.
MS Project
2mo
Save
Mark Applied
Hide
Manager, Regulatory Affairs
Santa Monica or Foster City or El Segundo or Thousand Oaks
$133k-$172k/yr HybridFull Time
5+ YOEBS +7 years or MS +5 years regulatory affairs experience; in-depth knowledge of ICH and regional regulatory requirements; experience preparing regulatory submissions, labeling and packaging input; strong communication and organizational skills.
1d
Save
Mark Applied
Hide
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
1mo
Save
Mark Applied
Hide
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.
1mo
Save
Mark Applied
Hide
Regulatory & Permitting Lead
Redwood City, California, United States
OnsiteFull Time
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.
2w
Save
Mark Applied
Hide
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)
1mo
Save
Mark Applied
Hide
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
2mo
Save
Mark Applied
Hide
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.
2mo
Save
Mark Applied
Hide
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.
2w
Save
Mark Applied
Hide
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
1w
Save
Mark Applied
Hide
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
2w
Save
Mark Applied
Hide
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.
2mo
Save
Mark Applied
Hide
Sr. Manager/Associate Director, Regulatory Affairs
Menlo Park or Waltham or United States
$161k-$208k/yr HybridFull Time
8+ YOEBachelor's in life sciences required, advanced degree preferred. RAC a plus. 8+ years regulatory affairs experience in biotech/pharma with IND/CTA and global submissions, FDA interactions, and strong regulatory planning skills.
2mo
Save
Mark Applied
Hide
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
2d
Save
Mark Applied
Hide
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
1w
Save
Mark Applied
Hide
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
2mo
Save
Mark Applied
Hide
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.
Explore Jobs