Quality and Regulatory Architect

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:
We are looking for an experienced
Quality and Regulatory Architect - Freelancer.
In this new role you ensure that a product under development by an Agile Release Train (ART) does meet the international quality and regulatory requirements for medical devices (MDR, MDSAP, ISO 13485, FDA etc). You achieve this by defining, reviewing and communicating product requirements and architectural concepts for an ART. You act in a pragmatic manner and help us strive for the least burdensome approach. You play a critical role in aligning teams on the ART to a shared direction and partner with agile teams in elaborating the solution, validating assumptions, evaluating implementation alternatives, and creating the Continuous Delivery Pipeline.

*As a Quality and Regulatory Architect you will:*

• Collaborate closely with business stakeholders, teams, expert functions and third-party stakeholders in defining the Q&R product strategy, medical device requirements and ensure adherence to product implementation strategy
• Plan ahead of the current program increment to ensure the external dependencies are achievable, such as reviews by notified bodies, submissions to competent authorities, studies to be conducted etc
• Participate in planning, definition, and high-level design of the solution and exploration of solution alternatives
• Close collaboration with Epic and Business Owners, Product Management, other Architects and Release Train Engineers to develop, analyse, split, and realise the implementation of enabler epics
• Coordinate with other internal and external experts ahead of time to ensure product strategic questions are resolved before active product development is started
• You work proactively with the Agile teams to ensure that emergent design choices are made with an understanding of the overall solution and minimise complexity
• Guide Enablers through the Program Kanban systems
• Operate within an economic framework when analysing the impact of design decisions and analyse trade-offs
• Enable those who implement value by empowering them to make local decisions, allowing faster flow of work and better economics

*Essential skills for your mission:*

• Multiple years of experience of regulations and standards for Medical Device - preferably software devices (Medical Device Regulation (EU) 2017/745, ISO 13485, IEC 62304 and IEC 82304)
• Experience leading or participating in Notified Body and/or FDA audits
• Experience leading and coordinating teams in a matrix environment
• Experience working in agile environments
• Ability to translate quality and regulatory requirements into practical implementations for the organization
• Excellent written and verbal communication skills in English
• Enjoy learning new things and thinking outside the box
• Willingness to working in cross functional and cross organizational teams for knowledge sharing and constant simplification

*Bonus skills:*

• SAFe Architect 6 or Leading SAFE 6 certification or other agile scaling framework
• Knowledge of the diabetes industry or other comparable health industries
• Technical understanding and love for innovative apps or software development
• Experience in ISO 27001 and MDSAP

*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
• 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
• 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 Just click that "Apply Now" button and send us your CV in English …. and anything else that you think might impress us.

Roche is an Equal Opportunity Employer.