What are the responsibilities and job description for the Medical Device Risk Manager (m/f/d) - Temporary position at 6935 mySugr GmbH?
Diabetes is a pesky monster — and that’s putting it mildly. If you’re serious about helping us face it head on, come join us! For a behind-the-scenes look, check out our Monster Culture blog, this little video and Roche code4life to see what makes mySugr and Roche tick.
Here's what we're looking for: Full time Temporary - 2 years An Expert with profound knowledge in Medical Device Risk Management to support the overall Risk Management efforts at mySugr in accordance with ISO14971.You will ensure compliance with the Medical Device Risk Management process of mySugr and maintain Risk Management files for EU class IIb and IIa medical devices. In this role you will work with cross functional product development teams to apply Risk Management during all design phases for new products and/or product updates. As a Risk Manager you will ensure that you stay up to date on new regulations and standards that affect Risk Management for medical devices and also drive knowledge transfer on Risk Management related topics to the organization. We’d love to talk to you if you want to be part of our mission and our growing team. Essential skills for your mission: ● Minimum 3 years of professional experience in the area of Medical Device Risk Management (class II/class III) in the EU and/or US ● Ability to work very structured and detailed, with high ability to spot inconsistencies ● Ability to manage Risk Management aspects of projects including planning, deliverables and priorities ● Profound knowledge of ISO 14971 and familiarity with associated standards (IEC 62304, IEC 62366, etc) ● Experience in working on overlapping projects - i.e. good at juggling multiple projects, multitasking and organizing yourself ● Passion for interacting with people and understanding their needs ● Energetic and outgoing personality ● Team spirit and love to work in an open, iterative and collaborative way ● Confident speaking in front of others and moderating risk management sessions ● Great written and verbal communication skills in English ● Willingness to working in cross functional, fast-paced corporations Bonus skills: ● Bachelor's degree (or equivalent experience) and wide-ranging related experience in the area of Medical Device Risk Management or Master's degree with several years of related experience ● Technical understanding and love for innovative apps or software development ● Medical background would be an asset ● Knowledge of the diabetes industry or other comparable health industries ● Experience working in startup environments What to expect: Ambitious and passionate people building meaningful products for a global audience An innovative agile working environment allowing for collaboration with really smart people and knowledge sharing in cross-functional teams A growing organization with room for development Not a corporate environment, but the leverage of a global market leader (Roche family) Loads of benefits (brand new Apple hardware, fitness, public transport, lunch benefit, language classes, professional training budget, chance to join global conferences...) Flexible working hours and home office policy, 5 weeks vacation A kick-ass office with a rooftop terrace, fully stocked kitchen and amazing barista coffee machines in the middle of Vienna… oh, and did we mention the best team in the world! Who we are and what we care about: Here at mySugr and Roche Diabetes Care we are committed to providing a healthy, equal and inclusive working environment for our Monster Tamers to help them make diabetes suck less and bring true relief to the patient! We care about family friendly career paths, sustainability, a healthy lifestyle and the flexibility of a modern workplace. We maintain a culture of learning and sharing, as well as open and candid feedback. At every level, there are many opportunities to develop and grow - both professionally and personally. Being a global leader in integrated Personalised Diabetes Management (iPDM), Roche Diabetes Care collaborates with pioneers around the globe, including people with diabetes, caregivers, healthcare providers and payers. We aim to transform and advance care provision and foster sustainable care structures. Under the brands RocheDiabetes, Accu-Chek and mySugr, comprising glucose monitoring, insulin delivery systems and digital solutions, we unite with our partners to create patient-centred value. By building and collaborating in an open ecosystem, connecting devices and digital solutions as well as contextualising relevant data points, we enable deeper insights and a better understanding of diabetes, leading to personalised and effective therapy adjustments. Interested? Great. We’d like to hear from you! In Austria, mySugr has a legal obligation to disclose the minimum salary according to our collective agreement, which is gross €€3,455 per month for this position. But! Rest assured, we offer amazing competitive compensation packages which take into consideration current market trends….. therefore you can expect a higher offer that reflects your experience level. Make sure to read our Privacy Notice for Applicants.
Here's what you can expect from us: A passionate team building meaningful products and services for patients with diabetes An innovative agile working environment allowing for collaboration with really smart people and knowledge sharing in cross-functional teams A growing organization with room for development Loads of benefits (brand new Apple hardware, fitness, public transport, lunch benefit, language classes, professional training budget, chance to join global conferences...) Flexible working hours and the opportunity for home office days, 5 weeks vacation A kick-ass office with a rooftop terrace, fully stocked kitchen and amazing barista coffee machines in the middle of Vienna… Oh, and did we mention the best team in the world!
Who we are and what we care about: Here at mySugr and Roche Diabetes Care we are committed to providing a healthy, equal and inclusive working environment for our Monster Tamers to help them make diabetes suck less and bring true relief to the patient! We care about family friendly career paths, sustainability, a healthy lifestyle and the flexibility of a modern workplace. We maintain a culture of learning and sharing, as well as open and candid feedback. At every level, there are many opportunities to develop and grow - both professionally and personally. Being a global leader in integrated Personalised Diabetes Management (iPDM), Roche Diabetes Care collaborates with pioneers around the globe, including people with diabetes, caregivers, healthcare providers and payers. We aim to transform and advance care provision and foster sustainable care structures. Under the brands RocheDiabetes, Accu-Chek and mySugr, comprising glucose monitoring, insulin delivery systems and digital solutions, we unite with our partners to create patient-centred value. By building and collaborating in an open ecosystem, connecting devices and digital solutions as well as contextualising relevant data points, we enable deeper insights and a better understanding of diabetes, leading to personalised and effective therapy adjustments.
Roche is an Equal Opportunity Employer. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.
Here's what we're looking for: Full time Temporary - 2 years An Expert with profound knowledge in Medical Device Risk Management to support the overall Risk Management efforts at mySugr in accordance with ISO14971.You will ensure compliance with the Medical Device Risk Management process of mySugr and maintain Risk Management files for EU class IIb and IIa medical devices. In this role you will work with cross functional product development teams to apply Risk Management during all design phases for new products and/or product updates. As a Risk Manager you will ensure that you stay up to date on new regulations and standards that affect Risk Management for medical devices and also drive knowledge transfer on Risk Management related topics to the organization. We’d love to talk to you if you want to be part of our mission and our growing team. Essential skills for your mission: ● Minimum 3 years of professional experience in the area of Medical Device Risk Management (class II/class III) in the EU and/or US ● Ability to work very structured and detailed, with high ability to spot inconsistencies ● Ability to manage Risk Management aspects of projects including planning, deliverables and priorities ● Profound knowledge of ISO 14971 and familiarity with associated standards (IEC 62304, IEC 62366, etc) ● Experience in working on overlapping projects - i.e. good at juggling multiple projects, multitasking and organizing yourself ● Passion for interacting with people and understanding their needs ● Energetic and outgoing personality ● Team spirit and love to work in an open, iterative and collaborative way ● Confident speaking in front of others and moderating risk management sessions ● Great written and verbal communication skills in English ● Willingness to working in cross functional, fast-paced corporations Bonus skills: ● Bachelor's degree (or equivalent experience) and wide-ranging related experience in the area of Medical Device Risk Management or Master's degree with several years of related experience ● Technical understanding and love for innovative apps or software development ● Medical background would be an asset ● Knowledge of the diabetes industry or other comparable health industries ● Experience working in startup environments What to expect: Ambitious and passionate people building meaningful products for a global audience An innovative agile working environment allowing for collaboration with really smart people and knowledge sharing in cross-functional teams A growing organization with room for development Not a corporate environment, but the leverage of a global market leader (Roche family) Loads of benefits (brand new Apple hardware, fitness, public transport, lunch benefit, language classes, professional training budget, chance to join global conferences...) Flexible working hours and home office policy, 5 weeks vacation A kick-ass office with a rooftop terrace, fully stocked kitchen and amazing barista coffee machines in the middle of Vienna… oh, and did we mention the best team in the world! Who we are and what we care about: Here at mySugr and Roche Diabetes Care we are committed to providing a healthy, equal and inclusive working environment for our Monster Tamers to help them make diabetes suck less and bring true relief to the patient! We care about family friendly career paths, sustainability, a healthy lifestyle and the flexibility of a modern workplace. We maintain a culture of learning and sharing, as well as open and candid feedback. At every level, there are many opportunities to develop and grow - both professionally and personally. Being a global leader in integrated Personalised Diabetes Management (iPDM), Roche Diabetes Care collaborates with pioneers around the globe, including people with diabetes, caregivers, healthcare providers and payers. We aim to transform and advance care provision and foster sustainable care structures. Under the brands RocheDiabetes, Accu-Chek and mySugr, comprising glucose monitoring, insulin delivery systems and digital solutions, we unite with our partners to create patient-centred value. By building and collaborating in an open ecosystem, connecting devices and digital solutions as well as contextualising relevant data points, we enable deeper insights and a better understanding of diabetes, leading to personalised and effective therapy adjustments. Interested? Great. We’d like to hear from you! In Austria, mySugr has a legal obligation to disclose the minimum salary according to our collective agreement, which is gross €€3,455 per month for this position. But! Rest assured, we offer amazing competitive compensation packages which take into consideration current market trends….. therefore you can expect a higher offer that reflects your experience level. Make sure to read our Privacy Notice for Applicants.
Here's what you can expect from us: A passionate team building meaningful products and services for patients with diabetes An innovative agile working environment allowing for collaboration with really smart people and knowledge sharing in cross-functional teams A growing organization with room for development Loads of benefits (brand new Apple hardware, fitness, public transport, lunch benefit, language classes, professional training budget, chance to join global conferences...) Flexible working hours and the opportunity for home office days, 5 weeks vacation A kick-ass office with a rooftop terrace, fully stocked kitchen and amazing barista coffee machines in the middle of Vienna… Oh, and did we mention the best team in the world!
Who we are and what we care about: Here at mySugr and Roche Diabetes Care we are committed to providing a healthy, equal and inclusive working environment for our Monster Tamers to help them make diabetes suck less and bring true relief to the patient! We care about family friendly career paths, sustainability, a healthy lifestyle and the flexibility of a modern workplace. We maintain a culture of learning and sharing, as well as open and candid feedback. At every level, there are many opportunities to develop and grow - both professionally and personally. Being a global leader in integrated Personalised Diabetes Management (iPDM), Roche Diabetes Care collaborates with pioneers around the globe, including people with diabetes, caregivers, healthcare providers and payers. We aim to transform and advance care provision and foster sustainable care structures. Under the brands RocheDiabetes, Accu-Chek and mySugr, comprising glucose monitoring, insulin delivery systems and digital solutions, we unite with our partners to create patient-centred value. By building and collaborating in an open ecosystem, connecting devices and digital solutions as well as contextualising relevant data points, we enable deeper insights and a better understanding of diabetes, leading to personalised and effective therapy adjustments.
Roche is an Equal Opportunity Employer. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.
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