At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come.
Creating a world where we all have more time with the people we love.
That’s what makes us Roche.
Our Digital Health Software products (SaMD and other digital health products) are used in hospitals, laboratories, and medical and health related establishments worldwide to provide insights to improve the diagnosis and treatment of patients and operations of hospitals and laboratories.
Who we are
Our Software Definition Department is searching for a talented individual to join us and bring Product Risk Management capabilities to our department.
You will be part of an ongoing transformation in the healthcare industry, working with our product teams to ensure we appropriately handle and document product, safety, and information security risks for our digital healthcare solutions.
The Opportunity
As a Product Risk Manager, you will oversee product risk management activities for our Software products, ensuring compliance with relevant regulations and internal processes. You’ll be supporting development activities, change control, complaints management, CAPA investigations, and you will support regulatory medical device and cybersecurity and data privacy reporting requirements for agencies such as FDA and European Competent Authorities.
You will work closely with R&D teams to ensure product risk management and quality processes are effectively integrated into product development. This includes supporting the implementation of risk controls and ensuring compliance with relevant standards.
Collaboration with cross-functional teams is key to aligning risk management practices across the product portfolio. You'll help identify and communicate risks that may impact other products and ensure proper documentation in quality systems.
Your role includes conducting risk assessments throughout the product lifecycle—from development to post-market activities. This involves reviewing usability, IT security, workflow-related hazards, and defects, while consulting with internal experts when needed.
You’ll verify that all risk control measures are implemented, tested, and traceable within tools like JIRA. Supporting documentation will be created and maintained in coordination with product and quality teams.
Finally, you’ll generate and update Risk Management Files for every product release or update, support audit readiness, and contribute to continuous improvement of risk review processes and tools.
We are looking for a motivated and committed person able to inspire our team oriented towards the values of passion, integrity and courage!
Moreover you bring
Educational Background: Bachelor's degree in Biomedical Engineering, Computer Science, Computer Engineering, or a related field, with over 5 years of experience in the software industry.
Risk Management Expertise: Minimum of 3 years of relevant experience in risk management for medical devices, including hands-on work in product risk management and technical documentation.
Regulatory & Quality Knowledge: In-depth knowledge of medical device regulations and standards such as ISO 13485, MDR/IVDR, FDA, and 21 CFR 820, with experience in risk analysis and ISO quality management systems.
Cybersecurity & Data Privacy: Experience with data privacy and cybersecurity standards and protocols, including ISO 27001, HITRUST, and GDPR, relevant to regulated digital health products.
Communication & Agile Experience: Strong ability to communicate complex technical concepts to non-technical audiences and translate between technical designs and product risks; experienced in Agile methodologies such as SAFe and Scrum.
Location: Sant Cugat (Hybrid model)
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.
