Regulatory Affairs Specialist, Medical Device Software
Dexcom Inc.
Dexcom Inc. in San Diego, CA is seeking a Regulatory Affairs professional to support software product development and submissions in the US, EU, and Canada. You will partner with cross-functional teams to develop regulatory strategies and ensure compliant labeling and promotion for software products. The role requires a Bachelor’s degree and 2–5 years of related experience, with a focus on medical device software and design controls (IEC 62304). #J-18808-Ljbffr Dexcom Inc.
- Dexcom Corporation is seeking a Regulatory Affairs professional to support regulatory activities for Dexcom software products and develop global regulatory strategies for... ...strong technical writing, knowledge of medical device software (IEC 62304), and ability to work...SoftwareMedical deviceRemote job
$71.6k - $119.3k
...scale stands before us.Meet the team:Regulatory Affairs is a team of more than 40 professionals... ...developmental activities for Dexcom software products.You will develop regulatory... ...requirements including design control, medical device submission requirements, labeling and...SoftwareMedical deviceWork at officeRemote workWorldwideHome officeFlexible hours- Regulatory Affairs Specialist/Senior Specialist We're currently supporting A global healthcare diagnostics... ...: 4+ years within a regulated medical device, IVD, pharmaceutical, or biologics environment... ..., laboratory automation, and software-enabled diagnostic platforms....SoftwareMedical device
$105.8k - $132.25k
Regulatory Affairs Specialist 3 - Medical Device IVD Location: CA-San Diego, US Contract Type: Regular Full-Time Area: TECHNICAL Would you like to join... ...to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices. Strong oral and written...SoftwareMedical deviceFull timeContract workWork at officeLocal area- ...Responsibilities The Associate Director of Regulatory Affairs will provide regulatory support for medical device systems within infusion technologies. The role... ...Affairs with complex medical device systems and software strongly preferred. Experience working with...SoftwareMedical deviceWork experience placementWork at officeRemote work
- ...delivered advanced business solutions for U.S. enterprises across biotech, medical devices, manufacturing, finance, and other highly regulated industries. Our teams bring deep expertise in software engineering, AI, Agentic solutions, data engineering, machine learning,...SoftwareMedical deviceFull time
$141.6k - $212.4k
...adoption of AI in data and analytics engineering workflows.Solid software engineering foundation — Git, REST APIs, JSON, CI/CD on at... ...or comparable regulated environments (life sciences, pharma, medical devices).Experience with Unity Catalog and lakehouse governance at...SoftwareMedical deviceFull timeLocal area$90k - $110k
...ago Be among the first 25 applicants Movemedical is the leading platform for advanced inventory management in the medical device industry. Our software transforms surgical planning, field inventory tracking, and supply chain coordination for some of the world’s...SoftwareMedical deviceWork at officeRemote workFlexible hoursShift work$143k - $215k
...platform capabilities that enable secure, reliable, and scalable software delivery. The ideal candidate has extensive experience... ...platform security controls.PreferredExperience in healthcare, medical device, financial services, or other regulated industries.Experience...SoftwareMedical deviceFull timeTemporary workWork experience placementFlexible hours- ...Sequencing and PCR applications. Familiarity with production software development lifecycle. Familiarity with best practices for software... ...automated software testing, preferably in the context of medical devices software such as bioinformatics analysis pipelines....SoftwareMedical deviceWork experience placementRemote work
- ...for U.S. enterprises across biotech, medical devices, manufacturing, finance, and other highly... ...internal stakeholders and external specialists or agencies, where applicable, to ensure... ...B2B marketing experience within software, technology, IT services, digital engineering...SoftwareMedical device
- ...San Diego, CA, seeks a Senior Android Software Engineer to design, build, and maintain... ...quality Android applications in a regulated medical device ecosystem. You will work at the... ...with embedded, cloud, cybersecurity, and regulatory teams to deliver reliable software that...SoftwareMedical device
- ...in San Diego, CA seeks a Senior Android Software Engineer to design, build, and maintain... ...Android apps that are part of the iLet medical device ecosystem. You will collaborate with embedded, cloud, cybersecurity, quality, regulatory, and clinical teams to deliver reliable...SoftwareMedical device
- ...in San Diego, CA seeks a Senior Android Software Engineer to design, build, and maintain... ...applications that are integral to our medical device ecosystem. You will work at the intersection... ...engineering, cybersecurity, quality, regulatory, product, and clinical teams to develop...SoftwareMedical device
$110k - $125k
...Join to apply for the Senior QA Engineer role at Movemedical We at Movemedical make the world’s best software solution for medical device companies. We’re looking for a Senior QA Engineer to build and lead the foundation of automated testing at Movemedical....SoftwareMedical deviceRemote workFlexible hours$91.7k - $137.53k
Job SummaryPosition Overview: The Senior Regulatory Affairs Specialist will lead activities which support both domestic and international regulatory... ...• Support initiatives to ensure regulatory approval of medical devices in both domestic and international markets. Provide...Medical deviceFull timeWork at office$152k - $227.98k
...of experience in solution architecture, software development, or technical leadership roles... ...comprehensive benefits package, including: • Medical, dental, and vision insurance • 401(k)... ...Massachusetts, is an innovative medical device company dedicated to simplifying life for...SoftwareMedical deviceFull timeWork at office- Beta Bionics, Inc. is seeking a Senior Android Software Engineer in San Diego, CA to design, build, and maintain Android applications that are integral to the iLet medical device ecosystem. The ideal candidate will combine strong software fundamentals with architecture...SoftwareMedical device
- ...Truvian Sciences is seeking a Director of Software Engineering to lead software development for its FDA-cleared TruVerus platform.... ...5+ years leading teams, and direct experience with regulated medical device software, design controls, and cloud platforms. #J-18808-Ljbffr...SoftwareMedical device
- ...the world's most innovative medical technology companies and a global... ...(IVD) products, cGMP and FDA regulatory compliance, and industry... ...8+ years of Biotech, Medical Device, or Pharmaceutical industry experience... ...other statistical analysis software.• Working knowledge of...SoftwareMedical device
- ...Sr. Software Test Automation Engineer (Automation Frameworks, Selenium, Postman, Jmeter, SQL... ..., Quality Standards, Azure, AWS, Medical Industry Experience DESCRIPTION:... ...cloud-based infrastructure and services, device software development and rich user experiences...SoftwareMedical deviceFull timeImmediate start
$55 per hour
...downgrade instructions for various country regulatory submissions. Ensure all documentation... ...in a regulated industry such as medical devices or pharmaceuticals. Extensive experience... ...more years writing and editing hardware/software user guides (print and online) and other...SoftwareMedical deviceContract work$114k - $228k
...Staff Software EngineerAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio... ...healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000...SoftwareMedical deviceNight shiftWeekend work- ...Director of Software (San Diego, CA - On-site) An innovative medical device company at a growth inflection point - with a product already in clinical studies -... ...cross-functionally with hardware, data science, regulatory, and executive stakeholders Own team budget,...SoftwareMedical deviceLocal areaImmediate startRelocation
- ...achieve project objectives. The ideal candidate should have a degree in engineering or computer science and a solid background in software development, along with excellent collaboration skills. Competitive compensation and comprehensive benefits are provided. #J-1880...SoftwareMedical device
$210k - $240k
...prototyping, product development, and micro‑manufacturing for the medical device industry. As we continue to expand across our global... ...Proficiency in Microsoft Office tools and project planning software Willingness to travel up to 40% Valid driver’s license Preferred...SoftwareMedical deviceContract workWork at office$118.2k - $177.2k
...possible.Join Illumina's Instrument Software Technical Product Management... ...with IoT and connected device architectures, edge computing... ...instrument platforms.Familiarity with medical device product development, risk analysis (e.g., FMEA), regulatory compliance (e.g., IEC 62304,...SoftwareMedical deviceFull timeLocal area$118k - $155k
...development, and micro manufacturing, driving innovation in the medical device industry. With rapid expansion across all our locations, we... ..., Medical Polymers and Ceramics) Experienced in applying software used on high precision micromanufacturing equipment (G-code,...SoftwareMedical deviceWork at office$95 - $105 per hour
A consulting firm is seeking a Senior Embedded Software Engineer for a contract role in San Diego, California. This position involves designing and maintaining real-time embedded software for medical devices, requiring extensive experience in C/C++ and RTOS. The ideal...SoftwareMedical deviceHourly payContract work$100k - $200k
...businesses and products in diagnostics, medical devices, nutritionals and branded generic... ...Device industry.7+ years of experience in software development involving database design.Bachelor... ...understanding of relevant legal and regulatory requirements, such as SOX, PCI, HIPAA,...SoftwareMedical deviceWorldwideShift work
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