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
Guy Carpenter: Marsh-owned global reinsurance broker and advisory firm serving insurers with analytics and capital solutions.
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.
Westcliff University: Private, for-profit university serving working adults with accredited degrees in business, technology, nursing, law, and education.
2+ YOEBachelor's degree required (Master's preferred),2+ years in higher education compliance/accreditation,knowledge of accreditation standards,project management and documentation skills,Microsoft Office proficiency.
StrykerNYSE: SYK: Global leader in medical technologies for orthopaedics, medical, surgical, and neurotechnology.
2+ YOEBachelor's degree in engineering, life sciences, regulatory affairs, or related field and 2+ years of regulatory affairs experience. Requires regulatory submissions and compliance experience; RAC and global submissions experience preferred.
Nihon Kohden OrangeMed, LLCTokyo Stock Exchange: 6849: Treasure Every Breath
3+ YOEBachelor's degree preferred; 3+ years of medical device regulatory experience, knowledge of FDA and international requirements, ISO 13485 and FDA 21 CFR Part 820, and strong documentation and communication skills.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, ERP systems, FDA eMDR
Marlborough or Irvine or Arden Hills or Maple Grove
$89k-$170k/yrHybridFull Time
Boston ScientificNYSE: BSX: Global medical technology leader providing innovative solutions for patients.
4+ YOEBachelor’s degree in a scientific or technical discipline, 4+ years of medical-industry regulatory affairs experience, and experience with 510(k), EU MDR, or international regulatory registrations.
Beckman Research Institute: Nonprofit biomedical research institute of City of Hope advancing cancer, HIV/AIDS, diabetes and other disease treatments.
2+ YOEPrepare and review regulatory submissions, support investigators and manufacturing/QC/QA teams, draft SOPs and protocols; 2+ years regulatory experience with Bachelors (or 0–2 with Masters).
CERENOVUS: A healthcare developing medicines, medical devices, and innovative health solutions.
2+ YOERequires a BS with 2+ years of experience or a PhD/MS, knowledge of US and European regulatory processes, strong communication skills, teamwork, and English proficiency; medical device regulatory experience preferred.
Research and Development (R&D), 510(k), IDE, PMA, HDE, EU MDR, ISO 13485
CERENOVUS: A healthcare developing medicines, medical devices, and innovative solutions.
2+ YOERequires a BS with 2+ years of experience or a PhD/MS, knowledge of US and European regulatory processes, strong communication skills, teamwork, and English proficiency. Medical device regulatory experience preferred.
Research and Development (R&D), 510(k), IDE, PMA, HDE, ISO 13485
Ormco: Private orthodontic medical-device manufacturer serving orthodontists with brackets, aligners, digital bonding, and laboratory solutions.
2+ YOEBachelor's degree, 2+ years regulatory affairs experience in medical devices (or Master's +1 year). Strong EU MDR knowledge (CER, SSCP, PSUR, PMS). Experience with international submissions and regulatory strategy.
Kaiser Permanente: Integrated managed care consortium and healthcare provider system.
3+ YOEBachelor's degree or 3+ years clinical research experience; working knowledge of FDA/IRB regulations; preparing regulatory submissions, maintaining study documentation, and supporting quality assurance; BLS and clinical research certifications preferred.
Glidewell Dental: Dental laboratory and technology manufacturer providing restorative services, devices, and education to dentists worldwide.
5+ YOE5+ years regulatory affairs experience, experience with FDA 510(k)/PMA and international registrations, SOP and audit experience, strong analytical and communication skills.
Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Microsoft Outlook
Irvine or Marlborough or Arden Hills or Maple Grove
$89k-$170k/yrHybridFull Time
Boston ScientificNYSE: BSX: Global medical technology leader providing innovative solutions for patients.
4+ YOEBachelor's degree in a scientific, technical, or related discipline and 4+ years of medical industry regulatory affairs experience, including 510(k), EU MDR, or international registrations.
Pro-Dex, Inc.NASDAQ: PDEX: Public U.S. medical-device manufacturer designing and making powered surgical instruments for medical-device OEMs.
1+ YOEBachelor of Science and 1+ year of quality experience in medical device manufacturing. Requires ISO 13485 and 21 CFR QSR/cGMP knowledge, technical writing, regulatory research, and Microsoft Office proficiency.
Microsoft Word, Microsoft Excel, Microsoft Access, ERP, 21 CFR Quality System Regulations, ISO 13485, Medical Device Single Audit Program (MDSAP), EU MDR, UK MDR, RoHS, REACH, Prop 65, CAFDB, USFDA, Health Canada, OSHA, DTSC, OC Health, EPA, 510K, CE Marking
MedtronicNYSE: MDT: Global leader in medical technology and healthcare solutions.
4+ YOEBachelor's degree in science or engineering with 4+ years of medical device regulatory experience, or advanced degree with 2+ years. Requires FDA submissions experience; RAC and global regulatory experience preferred.
Investigational Device Exemption (IDE), Premarket Approval (PMA), 510(k), European Union Medical Device Regulation (EU MDR), ISO 13485, ISO 14971, CE Mark
Masimo: Medical technology developing noninvasive patient-monitoring technologies for clinicians and patients worldwide.
3+ YOE3+ years medical device regulatory experience (Class II/III), expert knowledge of FDA and international regulations, ISO 13485 and FDA/GMP experience, 510(k) submissions, MS Office proficiency, bachelor\u0002s degree preferred.
Microsoft Word, Microsoft Excel, Microsoft Access, Microsoft Outlook
Westlake Financial: Privately held automotive finance and lending.
3+ YOEBachelor's degree in a business-related discipline; three years of auto finance experience preferred. Requires regulatory knowledge, strong communication, prioritization, teamwork, and detail orientation.
Daybreak, Microsoft Word, Microsoft Excel, Microsoft Outlook, Microsoft PowerPoint, Microsoft Visio, UKG Wallet
Keck School of Medicine of USC: Private nonprofit medical school educating healthcare professionals, conducting research, and providing advanced patient care through USC.
2+ YOEBachelor's degree and minimum 2 years clinical research/regulatory experience; experience with IRB/FDA submissions, GCP/OHRP/FDA regulations, strong organization, problem-solving, and communication skills.
Match GroupNasdaq: MTCH: Public U.S. technology operating global online dating and social-discovery brands for people seeking relationships and connection.
5+ YOERequires 5+ years in Trust & Safety, product policy, or regulatory compliance; expertise in online harms, detection tooling, safety UX, regulatory frameworks, performance metrics, technical communication, writing, and reasoning.