Quality & Regulatory Affairs Manager

Outcomes4me, Inc.; Berlin; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

Outcomes4me, Inc. is seeking a Quality & Regulatory Affairs Manager in Berlin, Germany. The role involves ensuring compliance with regulatory standards, managing quality processes, and collaborating with various teams to uphold safety and effectiveness of the product. Ideal candidates will have a relevant degree and experience with Software as a Medical Device. Join us to make an impact in digital health and contribute to improving cancer care outcomes worldwide.

Qualifikationen

• Experience in Software as a Medical Device or software-integrated medical devices.
• Deep understanding of ISO 13485 & MDR (EU) 2017/745.
• Experience in regulatory submissions such as 510(k), Health Canada, MHRA is a plus.

Aufgaben

• Take ownership of regulatory affairs, quality management, and compliance.
• Ensure compliance with ISO 13485, MDR (EU) 2017/745.
• Coordinate post-market surveillance and act as Vigilance Responsible.

Kenntnisse

Regulatory submissions

Risk management

Software as a Medical Device (SaMD)

Fluency in English

Ausbildung

Degree in Biomedical Engineering, Regulatory Affairs, Quality Management

Jobbeschreibung

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 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.

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.

Your Profile

• 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.

Why Join Us?

• 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.