Lavori attuali relativi a Medical device software specialist - Rome - BSI
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Medical Device Software Specialist
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Rome, Italia Bsi A tempo pienoOverviewWe exist to create positive change for people and the planet. Join us and make a difference too! Job Title: Technical Specialist, Scheme Manager, Clinical Evaluation Specialist - SaMD. Reports to: Technical Team Manager. Location: Home Based – Global.We have exciting opportunities for medical device software specialists to join our Software team....
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Global SaMD Technical Specialist
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Rome, Italia Bsi A tempo pienoA leading standards organization is seeking a Technical Specialist to manage CE marking schemes for Software as a Medical Device (SaMD) from a home-based role in Italy. The ideal candidate will possess at least 4 years of software medical device experience and a Bachelor's degree. Responsibilities include planning technical assessments, managing client...
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Global Samd Technical Specialist
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Rome, Italia Bsi A tempo pienoOverviewA leading standards organization is seeking a Technical Specialist to manage CE marking schemes for Software as a Medical Device (SaMD). The ideal candidate will have at least 4 years of software medical device experience and a relevant Bachelor's degree. You will plan technical assessments, manage client projects, and provide expertise to ensure...
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!*marketing Specialist Tavi
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Senior Quality
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SaMD Technical Specialist
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Rome, Italia Bsi A tempo pienoA leading standards organization is seeking a Technical Specialist to join their Software team. The role involves managing technical assessments and certifications for medical devices on a global scale. Candidates should have at least four years of experience in software medical devices and relevant qualifications in engineering. The position offers a...
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Global Clinical QA Lead — Hybrid, Device Trials
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Rome, Italia Boston Scientific Gruppe A tempo pienoA leading medical solutions company is looking for a Principal Clinical Quality Assurance Specialist to ensure compliance in clinical trials and oversee quality assurance processes. This hybrid role involves collaboration with global teams in managing significant clinical device studies across multiple sites. The ideal candidate will have extensive...
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Medical Logistician
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Rome, Lazio, Italia International SOS Government Medical Services A tempo pienoCompany DescriptionInternational SOS Government Medical Services, Inc. delivers customized medical and security risk management and wellbeing solutions to enable our clients to operate safely and effectively in environments far from home. Founded in 1984, we operate in 92 countries providing integrated medical solutions to organizations with international...
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Medical Logistician
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Rome, Lazio, Italia International SOS Government Medical Services A tempo pienoCompany DescriptionInternational SOS Government Medical Services, Inc. delivers customized medical and security risk management and wellbeing solutions to enable our clients to operate safely and effectively in environments far from home. Founded in 1984, we operate in 92 countries providing integrated medical solutions to organizations with international...
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Rome, Italia Amazon A tempo pienoSr. Device Software Engineer, Amazon Leo GovernmentAmazon Leo is Amazon’s initiative to launch a constellation of 3,236 Low Earth Orbit (LEO) satellites to provide high-speed, low-latency broadband connectivity to unserved and underserved communities globally. Join our mission to close the digital divide and connect people, businesses, and governments in...
Medical device software specialist
4 giorni fa
We exist to create positive change for people and the planet. Join us and make a difference tooJob Title: Technical Specialist, Scheme Manager, Clinical Evaluation Specialist - Sa MDReports to: Technical Team Manager Location: Home Based – Global We have exciting opportunities for medical device software specialists to join our Software team. You will have the opportunity to work with medical device manufacturers across the globe, from dynamic start-ups through to established large manufacturers. We are seeking engineers with Sa MD (Software as a Medical device) in technical capacity which can include product design, development and/or testing. Purpose of the position To build, manage, develop, control and manage a portfolio of Medical Device CE marking schemes. To deliver technical documentation assessments in support of the CE marking schemes. To provide Medical Device expertise leadership and mentoring in areas of competence to Healthcare personnel. Key Responsibilities & Accountabilities Plan and deliver Technical File Assessments, Design Examinations and Unannounced Audits to support EC Certification. Manage client projects, acting as their primary contact and after satisfactory assessment, to make certification recommendations for CE, UKCA and ISO 13485 certificate issue to ensure compliance with required certification, timely delivery of services and client satisfaction. Act as technical support to the commercial team when required to support business development and marketing activities as it grows the customer base worldwide. Perform unannounced visits to medical device manufacturers globally as a technical expert to check on compliance with certification. Work with Line Manager and other team leaders as required to provide reviews within area of expertise. Qualifications Degree educated (Bachelor's minimum or equivalent) relevant to medical device design, development, manufacture and use i.e. electro-mechanical, electronic/electrical, biomedical engineering, computer science, medical physics or similar4 or more years of Software Medical Device experience in a technical capacity, preferably within product design, development and/or testing. Interpretation and applications of International and National standards for the design, development and regulation of software medical devices. Understanding of Risk Management and FMEA of Software Medical Devices. Broad technical understanding of medical devices. Understanding of companies operating in these spaces and current industry trends. What we offer BSI offers a competitive salary, ample annual leave/paid time off, and other robust benefits depending on country. We invest strongly in the development of our experts, a highlight being an annual conference where our hundreds of experts come together for intensive and exciting continued professional development. About Us BSI is a business improvement and standards company and for over a century BSI has been recognized for having a positive impact on organizations and society, building trust and enhancing lives. Today BSI partners with more than 77,500 clients in 195 countries and engages with a 15,000 strong global community of experts, industry and consumer groups, organizations and governments. Utilizing its extensive expertise in key industry sectors - including automotive, aerospace, built environment, food and retail, and healthcare - BSI delivers on its purpose by helping its clients fulfil theirs. Living by our core values of Client-Centricity, Agility, and Collaboration, BSI provides organizations with the confidence to grow by partnering with them to tackle society's critical issues – from climate change to building trust in digital transformation and everything in between - to accelerate progress towards a better society and a sustainable world. BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.#J-18808-Ljbffr