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.
12+ YOE12+ years medical device regulatory experience with direct submission ownership; bachelor's in a scientific discipline required; RAC and advanced degree preferred; knowledge of FDA, EU, ISO standards; Microsoft Office and Adobe proficiency.
Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Adobe Acrobat
12+ YOEBachelor's in a scientific discipline, 12+ years medical device regulatory experience with direct submission responsibility; knowledge of 21 CFR, 510(k), EU directives/MDR, ISO 13485, ISO 14971; RAC preferred; Microsoft Office and Adobe Acrobat proficiency.
Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Adobe Acrobat
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.
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.
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.
Noah Medical: Building robotic platforms for early medical diagnosis and treatment.
5+ YOEBachelor's in engineering/life sciences/regulatory field, 5+ years medical device regulatory affairs experience, experience with FDA 510(k) and international registrations, strong knowledge of FDA, EU MDR, ISO 13485, ISO 14971, MDSAP; RAC preferred; Microsoft Office and eQMS proficiency.
Microsoft Office, electronic Quality Management Systems (eQMS)
MedlineNasdaq: MDLN: Manufactures and distributes medical supplies and clinical solutions.
2+ YOEBachelor's in safety/environment/business preferred, 2+ years EHS experience, Microsoft Office, OSHA 10/30 knowledge, incident investigation and regulatory reporting, up to 30% travel.
OneMain FinancialNYSE: OMF: Provides personal loans and credit cards to nonprime consumers.
High school diploma or GED required. Sales, collections, or customer service experience preferred; Spanish bilingual ability preferred. Must manage loans, serve customers, and maintain regulatory compliance.
San Juan or Salt Lake City or Herndon or Richmond or Renton or Spokane or Charleston or Milwaukee or Casper or Vestavia Hills or Anchorage or Fairbanks or Juneau or Scottsdale or Little Rock or Alameda or Fresno or Lawndale or Long Beach or Riverside or Sacramento or San Diego or San Jose or Van Nuys or Denver or Enfield or Miramar or Orlando or Tampa or Hapeville or Honolulu or Boise or Des Plaines or Springfield or West Chicago or Plainfield or Ankeny or Wichita or Louisville or Baton Rouge or Portland or Glen Burnie or Burlington or Belleville or Grand Rapids or Minneapolis or Jackson or Kansas City or Saint Ann or Helena or Lincoln or Las Vegas or Reno or Saddle Brook or Albuquerque or Farmingdale or Garden City or Latham or Rochester or Charlotte or Greensboro or Fargo or Cincinnati or Columbus or North Olmsted or Oklahoma City or Hillsboro or Allentown or New Cumberland or Philadelphia or Pittsburgh or West Columbia or Rapid City or Memphis or Nashville or Houston or Irving or Lubbock or San Antonio
$95k-$148k/yrOnsiteFull Time, Temporary
Federal Aviation Administration: Regulates civil aviation and manages national air traffic systems.
1+ YOE1+ MgmtAt least one year of specialized experience equivalent to FV-I/FG/GS-13, leading diverse teams and evaluating operations for policy and regulatory compliance; noncitizens are not eligible.
Algorithm Compliance Specialist - Global Security Organization
San Jose, California, United States
$112k-$180k/yrOnsiteFull Time
TikTok: Global short-form video hosting and social media platform.
3+ YOEDeep knowledge of recommendation systems, Python and SQL proficiency, ML frameworks (PyTorch/TensorFlow), experience with global AI/regulatory frameworks and compliance programs, strong analytical and communication skills.
NokiaNYSE: NOK: Sells telecommunications infrastructure and software for global network operators.
Develop and deliver training for photonic semiconductor manufacturing, manage document lifecycle and records, administer the LMS, conduct audits and assessments, ensure ISO and regulatory compliance, and support site ramp-up.
City of San José: Provides governance, public safety, and infrastructure for San José.
4+ YOE2+ MgmtBachelor's degree, 4 years environmental program experience including 2 years leading people or projects; knowledge of solid waste permitting, inspections, and enforcement; Form 700 disclosure; strong regulatory and communication skills.
Microsoft Outlook, Microsoft Word, Microsoft PowerPoint, Microsoft Access, Microsoft Excel, Solid Waste Information System (SWIS)