3+ YOE3+ years medical device regulatory experience preparing EU MDR technical documentation, CERs, PMS/PMCF, and international submissions; bachelor\u0002s degree in life sciences/engineering/regulatory affairs; strong regulatory writing and project management.
Microsoft Excel, Microsoft Outlook, Microsoft PowerPoint, Microsoft Word, Microsoft Teams
JSI: Provides engineering and consulting services for broadband network providers.
9+ YOE2+ Mgmt7–12 years regulatory and compliance experience in telecom, leadership/supervisory, account management, strong client service, and regulatory analysis skills.
Microsoft Office Suite, SmartSheets, Adobe Acrobat
VB Spine: A privately held medical technology developing innovative spinal technologies and supporting surgeons and patient outcomes.
7+ YOEBachelor’s degree in science, law, regulatory affairs, engineering, or equivalent; 7+ years of medical device or pharmaceutical regulatory experience; RAC preferred and strong regulatory strategy expertise.
Sr. Engineer, Regulatory Affairs and Certification, Vehicle Safety
Washington or Ann Arbor
HybridFull Time
Mitsubishi Motors North AmericaTokyo Stock Exchange: 7211: Sales and distribution of Mitsubishi brand vehicles and parts.
5+ YOEFour-year automotive engineering degree or equivalent, 5+ years automotive development experience, competence in safety regulatory and certification domains, Microsoft Office proficiency, strong research and communication skills.
VB Spine: A privately held medical technology developing spinal technologies and supporting surgeons.
7+ YOEBachelor’s degree in science, legal, regulatory, engineering, or equivalent; 7+ years of medical device or pharmaceutical regulatory experience; RAC preferred; strong regulatory and stakeholder skills.
VB Spine: A medical technology developing innovative spinal technologies and supporting improved patient outcomes.
7+ YOEBachelor's degree in science, legal, regulatory, engineering, or equivalent; 7+ years of medical device or pharmaceutical regulatory experience; regulatory pathways, submissions, compliance, and post-market expertise.
Director, Regulatory Affairs – Regenerative Medicine & Biologics Quality
Washington, District of Columbia, United States
$135k-$377k/yrOnsiteFull Time
IQVIANYSE: IQV: Provides clinical research and healthcare data analytics services.
5+ YOEBachelor's in scientific/engineering/regulatory required; MS/PhD preferred; 5+ years FDA-related regulatory affairs experience across human medical products; project/people management experience; knowledge of FDA, ICH, ISO; strong writing and analytical skills.
Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft PowerPoint
IQVIANYSE: IQV: Provides clinical research and data analytics for pharmaceutical companies.
15+ YOE3+ MgmtMinimum 15 years in Regulatory Affairs for medical devices/drugs/biologics; 3-5 years people management; bachelor’s in science/engineering; MS/PhD preferred; regulatory experience with FDA/Notified Bodies and submissions.
ViasatNASDAQ: VSAT: Provider of global satellite-based connectivity and secure communication solutions.
10+ YOE10+ years' relevant experience, master’s in EE/engineering/math/science, deep knowledge of satellite communications, ITU and FCC regulations, programming and interference analysis skills, travel 10–20%, US citizenship required.
ITU Space Network Systems (SNS), Licensing and Management System (LMS), 3GPP, ETSI
ViasatNASDAQ: VSAT: Provides global satellite broadband and secure networking communication services.
10+ YOE10+ years relevant experience, Master’s in a technical discipline, US citizenship, knowledge of satellite RF systems, ITU and FCC regulations, programming and interference analysis skills, travel up to 10-20%.
ITU Space Network Systems (SNS), Licensing and Management System (LMS), 3GPP, ETSI
5+ YOEMaster's degree in engineering or related technical field, 5 years in regulatory affairs, medical device and SaMD standards experience, and expertise monitoring regulations and writing policy documents.
Software as a Medical Device (SaMD), Cloud-native Quality Management Systems, ISO 13485, ISO 42001, IMDRF, ISO/IEC, AAMI
Rancho Cucamonga or Philadelphia or San Juan Capistrano or Washington or Atlanta or Lexington or Louisville or Boston or Raleigh or Houston or Bellingham or Madrid or United States or Canada or Mexico or Spain or Chile or Brazil
$100k-$150k/yrRemoteFull Time
ALL4: Provides strategic environmental health and safety consulting services.
5+ YOEBachelor's in engineering or environmental/science plus 5+ years environmental consulting; knowledge of air permitting (NSR, Title V, TRI, etc.); project management, client development, regulatory relationships, and strong written/verbal skills with Microsoft Word and Excel.