- Oracle (St. Paul, MN)
- …Oracle's success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work in ... as Regulatory Affairs, Quality Compliance, Product Development, etc. in medical device industry or equivalent. Experience authoring submissions (510k, EU… more
- Meta (New York, NY)
- …scientific discipline or equivalent work experience 6. 6+ years of industry experience in medical device regulatory affairs or related industry 7. Experience ... a regulatory affairs specialist to join our medical devices compliance team. You will get...get to work on wearables and Software as a Medical Device (SaMD) applications for the US… 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 ... Description:** Johnson & Johnson is hiring for a **Principal Regulatory Affairs Specialist- Shockwave Medical ** to join...for a **Principal Regulatory Affairs Specialist- Shockwave Medical ** to join our team. The position is **FULLY… more
- BeOne Medicines (San Mateo, CA)
- **General** **Description:** The Regulatory Affairs Director Dx/CDx and Medical Devices will be responsible for leading a small team for developing and ... implementing regulatory diagnostic and medical device ...externally with a solid background in medical devices /diagnostic development regulations and associated regulatory deliverables.… more
- West Pharmaceutical Services (Exton, PA)
- … regulatory requests. **Essential Duties and Responsibilities** + Develop and implement medical device regulatory strategies for West's administration and ... system product portfolio with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices ...5 years of relevant experience + 2+ years of medical device regulatory experience preferred… more
- Sanofi Group (Morristown, NJ)
- …teams + Develop and execute innovative and sustainable medical device regulatory strategies covering stand-alone medical devices and device part ... Sanofi's regulatory framework, providing expert guidance on medical device regulatory requirements across...to internal regulatory processes and procedures for medical devices + Accountable for regulatory… more
- Edwards Lifesciences (Irvine, CA)
- …clinical investigations, etc.). . Monitoring legal developments applicable to the Healthcare Regulatory and medical device spaces. . Other duties ... as needed.** **How you'll make an impact:** The Manager, Regulatory Counsel reports to the Senior Director, Regulatory...negotiating clinical trial agreements and associated contracts in the medical device or pharmaceutical industry or at… more
- Pentax Medical (Montvale, NJ)
- …for a FDA regulated employer + Thorough understanding of domestic and international regulatory requirements for medical devices + Experience with reusable ... imaging devices and solutions to the global medical community. Position Opening: Senior Regulatory Affairs...Affairs Specialist Why JOIN Us? We are an established medical device leader that is preparing for… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Duties** + Strategic Leadership and Portfolio Alignment: + Facilitate development of global regulatory strategies for medical devices and digital health ... technologies and data-driven solutions can transform healthcare beyond traditional medical devices . This leadership role leads an...of Regulatory Affairs experience, ideally within the medical device or digital health industries. +… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Specialist II contributes to the digital transformation in the medical device space. The role focuses on executing regulatory activities, monitoring evolving ... years prior regulatory affairs experience in the medical device industry, or a minimum of...sensitivity to cultural differences. + Familiarity with digital health regulatory frameworks for medical devices … more
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