- AbbVie (North Chicago, IL)
- …County, IL Primarily responsible for representing QA on cross-functional Software as a medical device ( SaMD ) and Digital Health Software product ... QA activities related to Software as a Medical Device ( SaMD ) and Digital...+ * Strong understanding of regulations and standards affecting software medical devices such as… more
- Meta (Burlingame, CA)
- …have deep domain experience in electromechanical devices and software as a medical device ( SaMD ). **Required Skills:** Head of Medical Devices ... regulators in particular for Software as a Medical Device ( SaMD ) products 11....of regulations, standards and guidance for medical devices (MDR, MEDDEV, MDCG, IMDRF, FDA QSR, SaMD… more
- Abbott (Pleasanton, CA)
- …Prior experience in a software -focused company or company with software as a medical device ( SAMD ). The base pay for this position is $144,100.00 - ... of FDA regulations and guidance, ISO 13485, Software Standards (eg, IEC 62304), EU Medical Device Regulations, and MDSAP **Preferred Qualifications**… more
- US Tech Solutions (San Bruno, CA)
- …+ Experience in Medical Device Manufacturing or Software as a Medical Device ( SaMD ). + Experience with Quality Management Systems (QMS). + 3+ ... + Managing cross-functional or cross-team projects to bring regulated medical device products to market. + Ensuring...audit readiness and regulatory submissions. + Support bringing novel medical devices from concept to release, manage… more
- Abbott (Burlington, MA)
- …in a software -focused company or company with software as a medical device ( SAMD ) + Experience developing or maintaining design controls for ... **_Staff Software Quality Engineer_** to ensure our medical devices are developed in accordance with...ISO 14971, Software Standards (eg, 62304), EU Medical Device Regulations and MDSAP **Preferred** +… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …CSSLP (Certified Secure Software Lifecycle Professional). + Prior experience in medical device security or related industries. + Familiarity with cloud-based ... functions, and the development teams to ensure the security of software products throughout their lifecycle, including compliance with regulatory requirements, risk… more
- Microsoft Corporation (Atlanta, GA)
- … to our team. Responsibilities include: + Ensures compliance with regulations governing Software Medical Devices including ISO 13485, ISO 27001, and ... of the healthcare regulatory landscape, including SaMD and device CDS for the United States and Medical Device Software for the European Union… more
- Abbott (Alameda, CA)
- …and corrective and preventative action of medical devices , including software as a medica device ( SaMD ), in-vitro, diagnostic devices ... of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines....and Marketing to support mobile app deployment activities (for Software as a Medical Device … more
- Fresenius Medical Center (Lawrence, MA)
- …regulatory requirements and standards as they pertain to the development and release of medical devices . . Assist with various projects as assigned by a direct ... SaMD product development . IEC 82304 - Health Software . Understanding of how Agile Software ...and data privacy **Experience** . 2+ years of relevant experience in medical device cybersecurity and data… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …for supporting MMS Dispensing products consisting of Medical Devices and Non- Medical Devices along with associated Software and Accessories on a ... MMS Dispensing Medical Device and non- Medical device products and software ...of 10 years of strong Regulatory Affairs/Compliance experience in medical devices + Minimum of 5 years… more
- Medtronic (Los Angeles, CA)
- …to formulate the right strategies that are both rigorous and also efficient. We release medical device software at the "speed of consumers", a unique ... establishhigh quality requirements and user stories in compliance with SaMD guidelines for a diverse range of software...with Protobuf, JSON and YAML formats. + Knowledge of software applications, terminologies for medical devices… more
- Philips (Cambridge, MA)
- …required. + You have proven experience with Software as Medical Device ( SaMD ), and Ultrasound Imaging Devices (preferred). + You have a ... a minimum of 7 years' experience in Regulatory Affairs within FDA regulated Medical Device , with expertise in the Preparation, Authoring and Submission of… more
- Bayer (Indianola, PA)
- …experience in product testing / Electro-Mechanical Systems; + Software as a Medical Device ( SaMD ). **YOUR APPLICATION** Bayer offers a wide variety ... **Email:** hrop_###@bayer.com **Job Segment:** Quality Engineer, Biomedical Engineering, Compliance, Senior Quality Engineer, Medical Device Engineer, Engineering,… more
- Takeda Pharmaceuticals (Boston, MA)
- …digital solutions to patients and healthcare professionals (HCPs). Our team of software engineers and IT professionals share a passion for building trail-blazing ... + Ownership of cross-functional team alignment and delivery by working with software developers, testers, project managers, business, and compliance teams to deliver… more
- Medtronic (Houston, TX)
- …in a complex, quota-driven sales role **DESIRED / PREFERRED QUALIFICATIONS** + Medical device /equipment sales experience. + Experience selling to physicians in ... independently. + Enterprise level technical sales, with life science, healthcare, or software (SaaS, PaaS, SaMD ) background strongly preferred + Proven… more