- GE HealthCare (Madison, WI)
- …by the Regulatory Affairs Professionals Society (RAPS). + Experience in medical device regulatory affairs + Demonstrated life-long learner; ... pulse oximetry. You will work within a team of Regulatory Affairs professionals to ensure GE HealthCare...labeling compliance, etc. GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is… more
- Philips (Cambridge, MA)
- …of 8+ years' Regulatory Affairs experience within FDA regulated Medical Device /HealthTech product environments. Experience with Software as Medical ... As a critical member of the Philips Ultrasound- Regulatory Affairs Organization, the Principal ...Technical Documentation, 510(k), De Novo, PMA, and registrations of medical devices globally. + You're able to work in… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …Advanced degree preferred; medical training preferred. + Minimum 8 years of regulatory affairs experience within the pharmaceutical or medical device ... **Job Description Summary** As Associate Director, Regulatory Affairs , you will be responsible...strong and respected voice. + Comprehensive knowledge of US medical device regulations (FDA), Clinical Practice standards,… more
- Astrix Technology (Fort Worth, TX)
- …EC Certificates (MDD /MDR) and associated documentation. **Key Requirements:** + 4+ years in medical device regulatory affairs + Experience with European ... ** Regulatory Affairs Specialist** Clinical Fort Worth,...Supporting EU MDR compliance and lifecycle change management for medical devices. + Works closely with site regulatory… more
- Philips (Cambridge, MA)
- …**You're the right fit if:** + You've acquired 5+ years of experience in the medical device regulatory affairs and/or quality assurance field. Experience ... **Senior Regulatory Affairs Specialist (Ultrasound)** The Senior Regulatory Affairs Specialist recommends process improvements, updates regulatory … more
- Sanofi Group (Cambridge, MA)
- …responsibilities. **About You** **Experience:** + 8+ years of experience within pharmaceutical or medical device Regulatory Affairs + Successful track ... **Job Title:** Director, US Regulatory Affairs - Advertising and Promotion...+ Dealt effectively with cross-functional groups, which may include Medical , Legal, Marketing, etc. + Experience managing others is… more
- Abbott (St. Paul, MN)
- …varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs required. Medical device industry experience preferred. ... and preclinical studies for product concept feasibility and formal regulatory submission. + Plan, coordinate, and conduct empirical and...or, Design Validation and GLP study experience in the medical device industry. + Demonstrated ability to… more
- Actalent (Irvine, CA)
- …(Master's preferred). + 8-10 years of experience in Quality Systems or Regulatory Affairs within the medical device industry. + Strong understanding of ... have a strong experience in quality systems within the medical device industry and a proven ability...SOPs with business and compliance needs. + Partner with Regulatory Affairs to ensure claims meet global… more
- Actalent (Minneapolis, MN)
- …Photoshop, and document management systems is a plus. + Knowledge of regulatory affairs and medical device labeling. + Graphic design and editing skills. ... 3-5 years of experience in technical writing or technical communications within the medical device industry. + Proficiency in Adobe InDesign and Microsoft Office… more
- Abbott (Pleasanton, CA)
- …from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs required. + Medical device industry experience. + ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more