Responsibilities Provides customer support on regulatory issues; Lead CE marking activities (per MDD and EU MDR), including preparation and maintenance of product technical files and clinical evaluations; Develops 510K submissions and obtains FDA approval; Supports product
About This Role Biogen is seeking a qualified candidate for the role of Senior Engineer II in the Device Development group. The Senior Engineer II, Device Development will contribute to the design, development, and lifecycle management
SI-BONE is a fast-growing, publicly traded medical device company that is an industry pioneer in minimally invasive sacropelvic solutions. Our mission is to help patients rise up and reach for the stars, and our vision is
Job Description The Chemistry Manufacturing Controls Manager – Device will support the execution of global regulatory CMC strategies for marketed and development drug-device combination products. This role contributes to the preparation and submission of regulatory CMC
Job SummaryThe Director of Design Assurance & Site Quality is the senior quality leader for the Design Center and responsible for leading and developing the local Quality organization. This role leads the local Quality organization, owns
Overview: Dozee Health AI is a pioneer in Contactless Remote Patient Monitoring (RPM), proven to drive transformation at scale. Headquartered in Bengaluru, India, Dozee has emerged as India’s no. 1 RPM Company. We are seeking visionary
Mission Neko is redefining what prevention means, from treating illness when it arrives, to sustaining health before its ever at risk. Our mission: make data-driven, preventative care accessible to more people, before symptoms appear. In a
Software Verification Manager, Medical Software Valencia, California – REMOTE Join a global leader in medical technology where innovation, quality, and patient impact come together. We are seeking an experienced Software Verification Manager to lead software verification
Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people
DentalMonitoring is a MedTech scale-up in a fast-growing medical field. We are looking for new talent to join our team! About DentalMonitoring DentalMonitoring is a leader in orthodontics, offering the industry’s first AI-powered remote monitoring solution
Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform
GROW WITH US: Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. We’d love for you to team up with us to
About Us Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop® system—the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple
About Meridian Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers
Job Description The Chemistry Manufacturing Controls Manager – Device will support the execution of global regulatory CMC strategies for marketed and development drug-device combination products. This role contributes to the preparation and submission of regulatory CMC
The Regulatory Affairs (RA) Manager of Global Labeling Compliance leads the end-to-end alignment of medical device labeling, packaging, and digital assets with evolving international regulations. This strategic role expands beyond traditional medical device labeling to oversee
Job Summary: Lead Human Factors Engineer possessing deep expertise in human factors engineering, usability engineering, and user-centered design to support and lead the development of safe, effective, and intuitive medical devices from concept through commercialization. Essential
The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock
At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented
At CoMind, we are developing a non-invasive neuromonitoring technology that will result in a new era of clinical brain monitoring. In joining us, you will be helping to create cutting-edge technologies that will improve how we