- J&J Family of Companies (Cincinnati, OH)
- … Device is required (4+ years with Advanced Degree). + Experience with medical device regulatory new product submissions **required** . + A demonstrated ... + Previous experience with health authority meetings/interactions + Experience with medical device software guidance, IEC 60601, sterilization, biocompatibility,… more
- J&J Family of Companies (Santa Clara, CA)
- …Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated ... internal departments to help efficiently and effectively meet assigned regulatory requirements for Shockwave Medical . The Senior...medical or other technical fields and Class II/III medical device experience is preferred. + Minimum… more
- BD (Becton, Dickinson and Company) (Durham, NC)
- …engineering, bioengineering, biology, chemistry); advanced degree preferred + Minimum 5 years of Regulatory Affairs experience in medical device or in vitro ... global regulatory agencies + Experience in negotiating with regulatory authority personnel in medical device and in vitro diagnostic areas +… more
- Medtronic (Irvine, CA)
- …experience + Or advanced degree with a minimum of 2 years of experience in medical device regulatory affairs **This is not a remote position** **Nice ... To Have** + 4 years of experience in medical device regulatory affairs + Excellent technical knowledge of medical products and understanding of relevant… more
- Oura (San Francisco, CA)
- … affairs, or a related field; advanced degree preferred. + 8+ years of regulatory affairs experience in medical devices , digital health, or wearable ... of the office. We are looking for a Director, Regulatory Affairs and Quality Assurance to play a key...external audits. + Deep understanding of software as a medical device (SaMD) and cybersecurity regulations. +… more
- Cardinal Health (Boston, MA)
- …+ Bachelors in related field, preferred + 2+ years' experience in Medical Device Regulatory Affairs/Quality experience preferred + Certification ... Private Brand, Presource, and Sustainable Technologies businesses and range of medical devices . + Maintain regulatory data, intelligence, and analytics… more
- Danaher Corporation (New York, NY)
- …and market access. The essential requirements of the job include: + 5+ years of regulatory experience in IVD medical devices , with a Bachelor's, Master's, or ... cross-functional design and development team to support both IVD medical device and Research Use Only (RUO)...regulations. + Knowledge of CE Marking processes, including for non- medical devices . Leica Biosystems, a Danaher operating… more
- Hologic (Newark, DE)
- …and partners with the international regulatory affairs group to support regulatory submissions worldwide for medical devices and includes support ... Regulatory Affairs Specialist 4 Newark, DE, United States...3+ Years with PhD + Experience working in regulated medical device industry + Experience with 483,… more
- Philips (Cambridge, MA)
- …the right fit if:** + You've acquired 10+ years of experience working in Regulatory Affairs within the medical device industry; Experience with ... **Director, Regulatory Affairs- Software and Artificial Intelligence (Ultrasound)** The...and all key stakeholders including R&D, Product Management, Quality, Medical & Clinical Affairs, and other functions at all… more
- J&J Family of Companies (Palm Beach Gardens, FL)
- …relevant regulatory experience (6+ years with Master's, 5+ years with PhD); Medical Device regulatory experience _strongly preferred_ . + Experience with ... US and European medical device regulatory processes **required** . + Experience in preparing and submitting US regulatory files (510(k)s, PMAs) as well… more
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