Compared with the selected benchmark ("All roles in Hamburg, Germany"), this listing's salary midpoint is about 92% lower. The offer sits below the benchmark range (€5,200–€9,700). The listed pay band (€500–€708) is tighter than the benchmark, which suggests lower salary variability. This benchmark is based on 2 comparable listings.

Monthly salary comparison for Regulatory & Quality Manager
Market	Lower bound (25th percentile)	Median	Upper bound (75th percentile)
All roles in Hamburg, Germany	€5,200/per month	€7,250/per month	€9,700/per month

About the role

Your mission is to transform complex regulatory requirements into practical, scalable solutions that support the development and successful certification of AI medical devices. As part of the Medical Excellence team, you will collaborate closely with Product, AI, Engineering, and Marketing to ensure that quality, regulatory compliance, and clinical value are integrated throughout the entire product lifecycle. Your responsibilities include owning and continuously improving our ISO 13485-certified Quality Management System, leading MDR conformity assessments and interactions with our Notified Body, preparing technical documentation for AI-powered medical devices, acting as the regulatory partner for interdisciplinary product teams, and supporting audits, risk management, and continuous improvement activities.

Job Details

Responsibilities

Own and continuously improve our ISO 13485-certified Quality Management System.
Lead MDR conformity assessments and interactions with our Notified Body.
Prepare technical documentation for AI-powered medical devices.
Act as the regulatory partner for our interdisciplinary product teams.
Support audits, risk management, and continuous improvement activities.

Requirements

Experience in Regulatory Affairs for medical devices, ideally under the EU MDR.
Bachelor's or Master's degree in Life Sciences, Medical Technology, Biomedical Engineering, Regulatory Affairs, or a related field.
Professional proficiency in English and German (written and spoken).
Strong written communication skills and the ability to prepare clear, structured documentation.