1,472 regulatory affair jobs at 802 companies in United States
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Senior Regulatory Affairs Specialist
San Diego, California, United States
$91k-$152k/yrHybridFull Time
DexcomNasdaq: DXCM: Manufacturer of continuous glucose monitoring systems for diabetes management.
5+ YOE5+ years regulatory affairs experience for medical devices, proficiency with US and EU device regulations, experience supporting 510(k)/license/technical documentation submissions, strong technical writing and communication.
Broadata Communications: Manufactures hardware for high-speed multimedia transmission over fiber optics.
8+ YOE8-10 years in Regulatory Affairs/Quality within medical devices; hands-on Class I; FDA 21 CFR Part 820, ISO 13485; DHF/DMR, labeling, audits; cross-functional collaboration.
Sunstar Americas: Manufactures oral care products and industrial chemical formulations.
3+ YOE3+ years regulatory/quality experience in US and Canada medical devices; authored a 510(k); Health Canada licensing experience; BS in science or related; strong writing and regulatory system skills.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, GUDID, UDI, US FDA electronic system
Michigan Primary Care Association: Supporting community health centers through advocacy, training, and technology.
3+ YOEJuris Doctor and at least 3 years of relevant legal practice required; Michigan bar admission preferred. Requires health law, healthcare compliance, regulatory affairs, communication, analytical, facilitation, and management expertise.
word processing, spreadsheets, database software, file and document management systems
Safeguard Medical: Manufacturer of emergency medical devices and trauma training equipment.
3+ YOEBachelor’s degree; at least 3 years regulatory affairs experience in medical devices or pharma; strong knowledge of domestic/global regulations; RAC a plus.
Eikon TherapeuticsNASDAQ: EIKN: Discovers drugs using advanced live-cell imaging and protein tracking.
10+ YOE10+ years regulatory affairs experience; FDA and international regulatory knowledge; clinical regulatory content and submissions; strong communication; individual contributor.
Duquesne Light Company: Provides electric energy transmission and distribution services in Pennsylvania.
Bachelor's degree in public policy/political science/communications/business, strong written/verbal communication, stakeholder relationship skills, regulatory affairs or public policy experience (2+ years preferred), cover letter and writing sample required.
AmeriVet Veterinary Partners: Operates a national network of community-based veterinary clinics.
Experience in regulatory affairs preferred, knowledge of veterinary regulatory guidelines, strong communication, research and analysis skills, able to manage multiple priorities and use document management/software tools.
Global Regulatory Lead, Regulatory Strategy - Global Regulatory Affairs - Infectious Disease/Vaccine
Indianapolis, Indiana, United States
$170k-$249k/yrOnsiteFull Time
Eli Lilly and CompanyNYSE: LLY: Researches and manufactures medicines for human health.
8+ YOE8+ years regulatory affairs or drug development experience (or 10+ with bachelor/master). Advanced scientific degree (PharmD/PhD) or relevant degree pathways; experience with FDA interactions and global regulatory strategy.
Director, Molecular Regulatory Affairs North America
Austin, Texas, United States
$194k/yrOnsiteFull Time
DiaSorinBorsa Italiana: DIA: Develops and manufactures in vitro diagnostic tests and laboratory equipment.
10+ YOE5+ MgmtAdvanced degree in life sciences or regulatory affairs preferred; 10+ years regulatory affairs experience with 5+ years leadership; experience with FDA 510(k)/PMA and Health Canada submissions; RAC a plus; strong leadership and regulatory strategy skills.
Thermo Fisher ScientificNYSE: TMO: Sells equipment and chemicals for scientific research and healthcare.
8+ YOE8+ years regulatory intelligence/affairs or 6+ with advanced degree; experience monitoring and assessing regulatory developments, policy analysis, briefing preparation, and working across functions in a matrix environment.
Air LiquideEuronext Paris: AI: Supplies industrial gases, medical gases, and related technologies.
Experience in regulatory affairs for cosmetics or nutrition, managing customer documentation portals, FDA compliance, KPI tracking, and cross-functional collaboration. Familiarity with regulatory databases and stakeholder communication; bachelor's in chemistry/biology preferred.
Lindus Health: An all-in-one clinical trial platform and research organization.
15+ YOE5+ Mgmt15+ years regulatory affairs in biopharma with 5+ years in a senior strategy role; led multiple FDA interactions; IND/NDA/BLA submission experience; program-level regulatory strategy and cross-functional coordination.
VitalConnect: Develops wearable biosensor patches for continuous wireless patient monitoring.
4+ YOERegulatory affairs director with 4+ years medical device experience; manage submissions, registrations, listings; maintain regulatory files; support audits and labeling.
Dispatch Bio: Develops universal immunotherapy treatments for solid tumor cancers.
2+ YOEBachelor’s in life sciences; 2+ years Regulatory Affairs in biotech/pharma; oncology/IND experience; strong communication; regulatory submissions; FDA/ICH knowledge.
Globus MedicalNYSE: GMED: Manufactures medical devices and robotic systems for musculoskeletal surgery.
2+ YOEPrepare and submit FDA regulatory submissions (510(k), IDE, PMA), review labeling and documentation, coordinate with cross-functional teams; 2+ years regulatory affairs experience in medical device industry; bachelor’s degree or equivalent.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Teams
DM Clinical Research: Regulatory specialist focused on regulatory oversight for clinical trials.
1+ YOEBachelor’s degree; at least 1 year of CRC experience; FDA/IRB/regulatory affairs experience; strong communication and MS Office; project management skills.
New York City or Boston or San Francisco or Salt Lake City or Milton Park or Montréal or London
$208k-$281k/yrRemoteFull Time
RecursionNASDAQ: RXRX: Developing medicines using an AI-native drug discovery platform.
10+ YOE10+ years pharma experience with 8+ years in global regulatory affairs; experience with major health authorities and regulatory submissions; strong regulatory strategy, communication, and cross-functional collaboration skills.