Medical Device Risk Manager - Freelancer (m/f/d)

F. Hoffmann-La Roche AG; Wien; On-site; EUR 85,000 - 110,000; Full time

Benefits offered by this job

Rooftop terrace office in Vienna

Fully stocked kitchen

Barista coffee machines

Job summary

Roche is seeking an Expert with profound knowledge in Medical Device Risk Management to support the overall Risk Management efforts at mySugr. You will ensure compliance with the Medical Device Risk Management process for EU class IIb/IIa devices and collaborate with cross-functional product teams to apply risk management throughout design stages.

The role requires up-to-date knowledge of ISO 14971, MDR/FDA regulations, and strong technical documentation skills.

Qualifications

• Minimum 3 years of professional experience in Medical Device Risk Management (class II/class III) in the EU and/or US.
• Excellent technical documentation skills within regulated quality systems.
• 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, ISO 13485, etc) and medical device regulations (MDR and/or FDA).
• Experience balancing overlapping projects with varying priority and multitasking.

Responsibilities

• Support the overall Risk Management efforts for mySugr in accordance with ISO14971.
• Maintain Risk Management files for EU class IIb and IIa medical devices.
• Apply Risk Management during all design phases for new products and updates.
• Stay up to date on new regulations and standards affecting Risk Management.
• Drive knowledge transfer on Risk Management topics across the organization.

Skills

Risk Management

ISO 14971

IEC 62304

IEC 62366

ISO 13485

MDR/FDA

Cross-functional

English communication

Education

Bachelor's degree

Job description

Let’s build a healthier future, together! By combining our unique strengths, we are redefining healthcare through sustainable action and innovation. For a behind‑the‑scenes look, check out this video to see how we at Roche are making personalized health care a reality. The mySugr GmbH was acquired by Roche in 2017 and our Vienna office is one of Roche's global sites. You will be located here, in the heart of Vienna, no matter if you work on a mySugr®, Accu-Chek®, navify® or any other Roche product or solution. You can read more about the history of mySugr & Roche here. Here's what we're looking for: 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
• Excellent technical documentation skills within regulated quality systems
• 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, ISO 13485, etc) and medical device regulations (MDR and/or FDA)
• Experience working on overlapping projects with varying priority - i.e. good at juggling multiple projects, multitasking and organizing yourself
• Ability to work in a highly structured, detailed manner and to spot inconsistencies
• 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

Here’s what you can expect from us:

• 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
• An amazing 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? We are committed to providing a healthy, equal and inclusive working environment for our employees to 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. As a healthcare pioneer committed to transforming the lives of billions of people around the globe, we push boundaries to redefine what is possible. We know that early, accurate diagnosis is essential to maintain health, prevent disease and help advance new, targeted treatments and potential cures for the world’s most serious health problems. We have a passion for innovation and a profound commitment to make a lasting impact on society by continuing to improve the standard of care for humankind. Our culture inspires us to create healthcare that is sustainable, efficient, and financially viable. Healthcare that is built on people’s needs, strong data and clinical insights. Healthcare that saves lives.

Interested? Great. We’d like to hear from you!

Rocheis an EqualOpportunityEmployer. 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, whatwedo, and how we do it. We are many, working as one across functions, across companies, and across the world. WeareRoche.