Quality & Regulatory Affairs Manager

outcomes4me

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!

About outcomes4me

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 making a tangible impact in digital health.
Work at the intersection of technology, medicine, and regulatory excellence global health tech leader
Ready to Make a Difference?

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.

Vigilance Responsible, including complaint handling and reporting.
Collaborate with cross-functional teams (e.g. Product, Tech, Customer Support) to ensure regulatory and quality alignment.
internal and external audits
risk and CAPA processes
Contribute to
employee training
and raise awareness for quality and compliance across the organization.
Degree in
Send your
CV & motivation letter

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