Quality Management Representative

Founded in May 2020, Noselab GmbH, based in Munich, Germany, focuses on a new, proprietary and groundbreaking platform for the detection, evaluation and characterization of molecular biomarkers through the analysis of nasal secretion. This unique method is complemented by an innovative, data-driven medical approach that enables comprehensive biomarker profiling, improves the understanding of diseases and supports personalized treatment decisions.

To support our continued growth and to ensure the robustness and further development of our quality and regulatory framework, we are seeking an experienced and motivated

In this key role, you will assume end-to-end responsibility for the implementation, maintenance, and continuous improvement of our Quality Management System in accordance with EN ISO 13485, the EU Medical Device Regulation (MDR), and other applicable harmonized standards. You will act as a central interface between internal stakeholders, external partners, notified bodies, and competent authorities, ensuring that quality, regulatory, compliance requirements are fully integrated into our daily operations and development activities.

Key responsibilities:

• Ownership for the implementation and continuous improvement of the quality management system (QMS) according to EN ISO 13485, the EU medical device regulation (MDR) 2017/245 and other harmonized standards as applicable
• Documentation of processes of the QMS including SOPs, work instructions, and records in coordination with different functions and process owners
• Coordination, preparation, attendance, documentation and follow-up of audits and inspections by the notified body, competent authorities or other external parties
• Preparation, execution, and documentation of internal audits and external supplier audits
• Ownership of the corrective and preventive actions (CAPA) process, including tracking and driving follow-up of actions
• Participation in the implementation of the risk management process
• Execution and monitoring of employee training on QM processes including documentation requirements
• Participation in development projects ensuring regulatory compliance and alignment with EN ISO 13485 when executing design and development and other relevant processes such risk management and change control
• Implement, maintain, and execute processes for post-market-surveillance and product recalls, ensuring that applicable reporting obligations are fulfilled.
• Act as the person responsible for regulatory compliance (PRRC) according to article 15, MDR, to ensure that the QMS and the company's products meet all applicable regulatory requirements and stay up to date with regulatory requirements.
• Communication and training of relevant regulatory requirements
• Develop international regulatory strategies and support projects for further development of the company's products and services
• Support the implementation and execution of the European privacy policy and other applicable regulations, including GDPR, in cooperation with the data security officer
• Manage external resources and advisors as required

Key Requirements:

• Advanced experience in quality management within the medical device industry, demonstrated by the successful implementation of quality management systems according to EN ISO 13485, including managing certification audits by Notified Bodies
• Professional experience in the field of authorization and conformity assessment of medical devices, in particular according to the MDR (EU) 2017/745, knowledge of IVDR (EU) 2017/746, ISO 15189 and (US) 510(k) advantageous
• At least 2 years experience in conducting audits; certifications (e.g. according to ISO
  19011) are required.
• Ideally, initial experience in data security requirements and applicable regulations
• Demonstrated experience in validating laboratory methods; including for computer-based systems is advantageous
  Independent, analytical and structured way of working with a high degree of responsibility
• Ability to work in a team, readiness and flexibility
• Fluent in written and spoken German and English
• Proficiency of working with electronic data systems, incl. standard office tools, as well as digital document control systems

What We Offer:

• High-autonomy key role with significant influence as well as broad and varied responsibilities, combining strategic and operational quality and regulatory activities on a part-time basis
• A dynamic, collaborative and purpose-driven work culture
• A permanent part-time position with competitive salary
• Flexible work setup with time on-site in Munich and home-office options