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!
Your Responsibilities- Take ownership of all aspects of regulatory affairs, quality management, and compliance – internally and externally – ensuring that all processes are aligned and well-coordinated.
- Ensure compliance with ISO 13485, MDR (EU) 2017/745, Class IIa, and other applicable standards.
- Maintain and evolve our Standard Operating Procedures (SOPs) and documentation.
- Coordinate post-market surveillance and act as Vigilance Responsible, including complaint handling and reporting.
- Collaborate with cross-functional teams (e.g. Product, Tech, Customer Support) to ensure regulatory and quality alignment.
- Support internal and external audits and manage risk and CAPA processes.
- Contribute to employee training and raise awareness for quality and compliance across the organization.
- Degree in Biomedical Engineering, Regulatory Affairs, Quality Management, or a related field.
- Experience of Software as a Medical Device (SaMD) or software-integrated medical devices.
- Deep understanding of ISO 13485 & MDR (EU) 2017/745.
- Experience in risk management, CAPA, post-market surveillance, and complaint handling.
- Experience in regulatory submissions (e.g., 510(k), Health Canada, MHRA) is a plus.
- Fluency in English (German is a plus).
- Strong team spirit, communication skills, and a structured way of working.
- Be part of a mission-driven company making a tangible impact in digital health.
- Work at the intersection of technology, medicine, and regulatory excellence.
- Join a global health tech leader.
Skills Required
- Degree in Biomedical Engineering, Regulatory Affairs, Quality Management, or related field
- Experience of Software as a Medical Device (SaMD)
- Deep understanding of ISO 13485 & MDR (EU) 2017/745
- Experience in risk management, CAPA, post-market surveillance, and complaint handling
- Experience in regulatory submissions (e.g., 510(k), Health Canada, MHRA)
- Fluency in English
- German language skills
- Strong team spirit, communication skills, and structured way of working
What We Do
Outcomes4Me is an AI-driven patient empowerment platform that helps cancer patients navigate their care and gain access to personalized treatment options. The company is on a mission to democratize healthcare by providing real-time, evidence-based clinical information to cancer patients, ensuring they can take a more active role in their own care. At the same time, Outcomes4Me is working to promote health equity by generating deeper insights that improve care, accelerate research, and lead to better outcomes. Based in Boston, Massachusetts, Outcomes4Me is a woman-led company of seasoned healthcare, oncology, pharmaceutical, consumer, and technology veterans.
Why Work With Us
We're fueled by innovation, inspired by patients, and motivated by our collective desire to help patients better navigate their medical choices. Our team is entrepreneurial to our core, working tirelessly to build solutions that live at the intersection of innovation, pharmaceuticals, biotech, and oncology.
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