- Beckman Coulter Diagnostics (Miami, FL)
- …regulations and standards including compliance with Food & Drug Administration (FDA), Medical Device Single Audit Program (MDSAP), ISO13485, European Union ... Medical Device Directives (MDD), and In-Vitro Medical ...not required but training and certificates in quality or regulatory affairs would be a plus (eg… more
- Cytiva (Miami, FL)
- …in Quality or Regulatory in a regulated industry (ISO 9001, medical device , or pharmaceutical preferred).Experience with root cause analysis, CAPA ... to the QA Senior Manager Site Quality Leader and is part of the Quality and Regulatory Affairs Team located in Shrewsbury, MA. and will be an on-site role.What… more
- Olympus Corporation of the Americas (Westborough, MA)
- …preferred, BS or comparable required + Minimum of 5-7 years experience in Regulatory Affairs in Medical Device Industry with focus on Software driven ... / Machine Learning-enabled medical devices + Expert in Regulatory Affairs for Software as a Medical Device and Class I/II/III medical devices.… more
- Medtronic (Minneapolis, MN)
- …+ Bachelor's degree required + Minimum of 2 years of experience in regulatory affairs in the medical device industry + Or advanced degree with a ... minimum of 0 years of experience in regulatory affairs in the medical device industry. **Nice to Have (Preferred Qualifications):** + Experience working… more
- Philips (Cambridge, MA)
- …the right fit if:** + You've acquired 7+ years of experience in Regulatory Affairs within the Medical Device industry. You have 2+ years of experience ... working with SaMD products in the Medical Device industry from a Regulatory Affairs perspective. You have authored multiple 510ks, and EUMDR tech files,… more
- Caldera Medical (Westlake Village, CA)
- …Sciences, Biomedical Engineering, or a related field. * 5-7 years of regulatory affairs experience in the medical device industry. * Strong understanding ... Regulatory specialist, you will develop and implement medical device regulatory strategies to...Excel, Office, PowerPoint, and Adobe). * Regulatory Affairs Certification (RAC). Who is Caldera Medical ?… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …is preferred. **Experience** * Minimum of five (5) years of Regulatory Affairs experience in the medical device and/or pharmaceutical industry. ... of possible** with us. **Job Overview** As a Staff Regulatory Affairs Specialist in Advertising/Labeling, you will...existing US and international regulations and directives (eg, FDA Medical Device Regulations, EU Low Voltage Directive,… more
- Olympus Corporation of the Americas (Westborough, MA)
- …and future approvals to management. **Job Qualifications** **Required:** + Regulatory affairs experience in the Medical Device industry is mandatory ... (https://www.olympusamerica.com/careers) . **Job Description** Assist the Manager, Regulatory Affairs in obtaining approval to market Olympus medical devices… more
- Hologic (San Diego, CA)
- …direct experience in Regulatory Affairs within the IVD or medical device industries. + Master's Degree in biomedical engineering and/or RAC preferred ... of 5-8 years direct experience in Regulatory Affairs within the IVD or medical ...Regulatory Affairs within the IVD or medical device industries. + Software/instrumentation experience strongly… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …The Associate Director of Regulatory Affairs will provide regulatory support for medical device systems within infusion technologies. ... * Minimum of 5 years of experience in Regulatory Affairs working with complex medical device systems and software strongly preferred. * Experience… more
- Imperative Care (Campbell, CA)
- …of education/training and experience. + An advanced degree or regulatory affairs experience in the medical device industry strongly preferred. ... Title: Sr Regulatory Affairs Specialist This position is...of experience in related roles at healthcare, pharma, or medical device industries; or an equivalent combination… more
- University of Utah (Salt Lake City, UT)
- …a 9-month (annually Aug. 16 - May 15) Career-line faculty position in the area of Regulatory Affairs , Medical Device Design and Regulatory Science. ... and strong interest in teaching Regulatory Affairs , Regulatory Science, and medical device design courses. Practical experience in regulatory … more
- Globus Medical, Inc. (Audubon, PA)
- …Engineering degree is a plus + Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry, , preferably within orthopedic ... their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist drafts, submits and gains...medical devices; + Experience in medical device development and registration of products… more
- Philips (Cambridge, MA)
- …experience in Regulatory Affairs within Global FDA regulated medical device /technology environments, and a minimum of 3+ years' experience successfully ... The Regulatory Affairs Program Manager will play...program/project teams in maintaining Global enterprise compliance for Unique Device Identification (UDI). + You have demonstrated Regulatory… more
- Teleflex (Chelmsford, MA)
- …in a science or engineering field, or equivalent work experience. * 5+ years of Medical Device Regulatory Affairs experience, domestic and international. ... Sr. Regulatory Affairs Specialist **Date:** Apr 9,...:11911 **About Teleflex Incorporated** As a global provider of medical technologies, Teleflex is driven by our purpose to… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …equivalent in Science or Engineering preferred + 8+ years in regulatory affairs and/or system engineering, or equivalent, medical device /IVD industry ... and standards applicable to Medical Devices, IVD Medical Devices, Software as Medical Device...Device throughout the product lifecycle. + Support the regulatory teams involved in the regulatory submissions… more
- Bristol Myers Squibb (Madison, NJ)
- …BSN, etc.) with 5 years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in ... careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion… more
- Actalent (Agoura Hills, CA)
- …Sciences, Biomedical Engineering, or a related field. + 5-7 years of regulatory affairs experience in the medical device industry. + Strong understanding ... Regulatory specialist, you will develop and implement medical device regulatory strategies to...(eg Microsoft Word, Excel, Office, PowerPoint, and Adobe). * Regulatory Affairs Certification (RAC). Pay and Benefits… more
- Corning Incorporated (Tewksbury, MA)
- …+ Current understanding of FDA and rest of world compliance trends in Regulatory Affairs as relates to biological products, medical device , IVDs etc. + ... Regulatory Affairs Specialist, Biologics **Date:** May...trends related to biological products, including media and serum, medical devices, IVDs and more + Knowledge of Biological… more
- Abbott (Atlanta, GA)
- …business unit model. + Experience working in the Medical Device industry. + Regulatory Affairs Professionals Society Certification ... place to work for diversity, working mothers, female executives, and scientists This ** Regulatory Affairs Specialist II** will work on-site out of our Atlanta,… more
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