Berlin, Germany · On-site
Join Us in Transforming Cancer Care At Outcomes4Me Germany, we’re transforming the way cancer patients are supported—through a personalized, data-driven, and evidence-based digital health platform. As part of the global …
Skills: Regulatory Affairs, Quality Management, ISO 13485, MDR (EU) 2017/745, Software as a Medical Device (SaMD)
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The manager will oversee all regulatory affairs, quality management, and compliance for a digital health platform. Key duties include maintaining SOPs, coordinating post-market surveillance, and ensuring alignment with ISO 13485 and MDR standards.
Candidates need a degree in Biomedical Engineering, Regulatory Affairs, or a related field with experience in SaMD. Deep knowledge of EU medical device regulations and risk management processes is required.
At Outcomes4Me Germany, we’re transforming the way cancer patients are supported—through a personalized, data-driven, and evidence-based digital health platform. As part of the global Outcomes4Me group (headquartered in the U.S.), we’re united by a shared mission: to empower patients, enhance the quality of care, and improve health outcomes worldwide.
Ensuring the highest level of quality, safety, and compliance is at the heart of everything we do. As Quality & Regulatory Affairs Manager, you will play a critical role in upholding these standards, ensuring that our app remains at the forefront of Software as a Medical Device (SaMD) while meeting the evolving regulatory landscape. If you're passionate about bridging innovation with compliance, this role is for you!
On a mission to democratize cancer patient care, one life at a time.
Outcomes4Me uses AI and machine learning to help cancer patients navigate their care and access personalized treatment information. When patients provide their health information, our free platform offers both doctor-approved and FDA-approved guidance based on their diagnosis, as well as relevant clinical trials and genetic testing the patient should consider. We are the first digital platform to integrate with the with the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®), from the not-for-profit alliance of 33 leading cancer centers. Recent accolades include: TIME Best Inventions of 2025, 2025 Inc. 5000, 2024 Fast Company World Changing Idea, 2024 MedTech Breakthrough Award, 2024 Anthem Award, BuiltIn Best Place to Work, and the MassTLC Tech Top 50: CEO of the Year Award.
Offices: One Beacon Street, 15th Floor, Boston, Massachusetts 02108, US
On a mission to democratize cancer patient care, one life at a time.
Outcomes4Me uses AI and machine learning to help cancer patients navigate their care and access personalized treatment information. When patients provide their health information, our free platform offers both doctor-approved and FDA-approved guidance based on their diagnosis, as well as relevant clinical trials and genetic testing the patient should consider. We are the first digital platform to integrate with the with the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®), from the not-for-profit alliance of 33 leading cancer centers. Recent accolades include: TIME Best Inventions of 2025, 2025 Inc. 5000, 2024 Fast Company World Changing Idea, 2024 MedTech Breakthrough Award, 2024 Anthem Award, BuiltIn Best Place to Work, and the MassTLC Tech Top 50: CEO of the Year Award.
Offices: One Beacon Street, 15th Floor, Boston, Massachusetts 02108, US
