JOIN THE JOURNEY!
We are looking to recruit an experienced Risk and Release Manager to join a great team working with important products.
Brighter is a health-tech company from Sweden with a vision of a world where managing chronic diseases is no longer a struggle. We believe a data-centric approach is key to provide smarter care for chronic conditions. Our daily-care solutions facilitate the flow of real-life treatment data between chronic-disease patients, their loved ones and their care providers – improving quality of life, easing the burden on healthcare systems, and opening new opportunities for data-driven research. Brighter´s quality system is certified under ISO 13485. In 2019 the company won the Swecare Rising Stars Award. For more information visit https://brighter.se/
As Risk and Release Manager you will coordinate and drive the risk management activities for the whole ADMS solution. Maintaining a safe product design throughout the life cycle of the products with the goal of having a safe and effective product for the end users. Making sure that the risk management process is aligned with applicable standards and Brighter routines and assisting the development teams with performing validation of computer software tools.
You will also lead the change activities of Brighter’s products from decided changes to market deployment in consistency with Brighter’s strategy, goals, quality management system, policies and procedures, and applicable regulatory requirements. The goal is a successful launch of new products and changes on existing products on the market. One of your responsibilities will be to facilitate events and processes and assist the teams in delivering value. You communicate with stakeholders, escalate impediments, manage risk, and drive improvement.
Main responsibilities include:
• Create risk management plans, hold the risk assessment sessions, perform risk management reviews and reports
• Maintain the Computer System Tools validation process
• Maintain the Risk Management process
• Support the teams in performing validation of computer software tools
• According to the solution team’s prioritization, plan and execute the necessary changes to Brighter’s products
• Develop a time schedule for the changes that estimates the time needed for all activities, maintain continuously and revise the schedule if required
• Execute the changes according to the plan and company’s quality management
• Ensure compliance of the project outputs with applicable regulatory requirements
The position reports to the System Development Lead and you will be based in Brighters headquarter in Kista.
To succeed we think you need
• Experience working as a risk manager or risk engineer
• Experience working according to a quality management system
• Knowledge of MDD/IVD, ISO 13485, EN ISO 14971, IEC 62366 and IEC 62304
• Knowledge of multiple technical components with regards to hardware, firmware, software and process development
• Ability to work with product team members and stake-holders of different technical expertise
• Experience in project management of medical device or similar experience from another regulated environment
• Experience from working with agile methods such as Scrum, Kanban or similar
• Good communication skills
Being a Brighterian
At Brighter we have a genuine interest in driving change, our mission is to improve the quality of life of millions of people's. That goes for our teams as well. Our values are Smart, Friendly and Reliable and that is the guiding star for our attitudes and behaviors. How we lead ourselves and work together sets our company culture, and we thrive on having a company culture where we team up and win together. For us it's important that you are a team player and want to contribute to improving the world and Brighter's future success!
We recommend that you submit your application as soon as possible as selection and interviews are held continually.
In this recruitment we collaborate with our partner Rekryteringsspecialisten. Do not hesitate to contact Erik Düring if you are curious about the role, 0708-999469.
Looking forward to meet you!