- Abbott (Santa Clara, CA)
- …executives, and scientists. **The Opportunity** We currently have several opportunities for the ** Medical Device Regulatory Affairs Development (RAD) ... to various international affiliates. + Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are… more
- Medtronic (Irvine, CA)
- …Medical Device Experience:** Minimum of 4 years of relevant experience in medical device regulatory affairs . + **510(k) Submission Experience:** ... or university required; advanced degree with a minimum of 2 years of experience in medical device regulatory affairs is a plus. + ** Regulatory … more
- Terumo Aortic (Sunrise, FL)
- …(or related field) from an accredited college or university and 3 years direct experience in medical device regulatory affairs + Minimum 5 years direct ... experience in medical device regulatory affairs if no degree. + Knowledge of US and European regulatory processes, including Class III is strongly… more
- 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
- 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
- GRAIL (Menlo Park, CA)
- …management within the IVD, medical device , or pharmaceutical industries. + Regulatory affairs and IVD device experience preferred. + An advanced ... FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such...and international regulatory frameworks and processes for medical device development and approvals. + Effective… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …is specifically focused on regulatory affairs for Software as a Medical Device (SaMD) products. The candidate will need deep expertise in FDA ... processes (ISO 14971) and cybersecurity for medical device . **Preferred Qualifications:** + Regulatory Affairs... medical device . **Preferred Qualifications:** + Regulatory Affairs Certification (RAC) + Experience with… more
- Hologic (Louisville, CO)
- Regulatory Affairs Specialist, Medical Device Louisville, CO, United States Marlborough, MA, United States **Join Hologic's Surgical Division as a ... You'll Bring:** **Experience** + 2-5 years in regulatory affairs , preferably within the medical device industry. + Proven experience preparing … more