Quality and Regulatory Architect (m/f/d)

Job description

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 (Vienna)

We are looking for an experienced Quality and Regulatory Architect. 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 

• A growing organization with room for development

• Loads of benefits (brand new Apple hardware, fitness, public transport, lunch benefit, language classes, professional training budget,...)

• Flexible 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!

Interested? Great! We’d like to hear from you! Please submit your resume, cover letter, and whatever else you would like to share!

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.

Roche is an Equal Opportunity Employer.