Quality Management Representative / Person Responsible for Regulatory Compliance (PRRC; m/w/d)

Person Responsible for Regulatory Compliance (PRRC; m/f/d)

Founded in May 2020, Noselab GmbH , based in Munich, Germany, is dedicated to developing a novel, proprietary and groundbreaking platform for the detection, evaluation and characterization of molecular biomarkers through the analysis of nasal secretions.

This unique technological approach is complemented by an innovative, data-driven medical methodology that enables comprehensive biomarker profiling, advances disease understanding and supports personalized treatment decisions.

To support our continued growth and to further strengthen the robustness and maturity of our quality and regulatory framework, we are seeking an experienced and motivated Quality Management Representative / Person Responsible for Regulatory Compliance (PRRC) to join our team on a part-time basis.

Your Role

In this key position, you will assume end-to-end responsibility for the implementation, maintenance and continuous improvement of Noselab’s Quality Management System (QMS) 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 and compliance requirements are seamlessly embedded into daily operations and development activities.

Key Responsibilities

• Overall ownership of the implementation, maintenance and continuous improvement of the QMS in accordance with EN ISO 13485, MDR (EU) 2017/745 and other applicable harmonized standards
• Creation, maintenance and optimization of QMS documentation, including SOPs, work instructions and records, in close collaboration with process owners and cross-functional teams
• Coordination, preparation, participation, documentation and follow-up of audits and inspections conducted by notified bodies, competent authorities and other external parties
• Planning, execution and documentation of internal audits as well as external supplier audits
• Ownership of the CAPA process, including tracking, implementation and effectiveness verification of corrective and preventive actions
• Active participation in the implementation and maintenance of the risk management process
• Planning, execution and documentation of employee training related to quality management processes and regulatory requirements
• Regulatory support of development projects, ensuring compliance with EN ISO 13485 throughout design and development, risk management, change control and related processes
• Implementation, maintenance and execution of post-market surveillance and product recall processes, ensuring compliance with all applicable reporting obligations
• Acting as the Person Responsible for Regulatory Compliance (PRRC) in accordance with Article 15 of the MDR, ensuring that the QMS and Noselab’s products consistently meet all applicable regulatory requirements and remain aligned with evolving regulations
• Communication and training of relevant regulatory requirements across the organization
• Development of international regulatory strategies and support of projects related to the further development of Noselab’s products and services
• Support of the implementation and execution of European privacy and data protection regulations (including GDPR) in cooperation with the Data Protection Officer
• Management and coordination of external consultants, service providers and advisors as required

Your Profile

• Extensive experience in quality management within the medical device industry, including the successful implementation and maintenance of QMS according to EN ISO 13485 and the management of certification audits conducted by notified bodies
• Professional experience in medical device authorization and conformity assessment, particularly under MDR (EU) 2017/745; knowledge of IVDR (EU) 2017/746, ISO 15189 and US FDA 510(k) processes is an advantage
• At least two years of hands-on experience in conducting audits; relevant certifications (e.g. ISO 19011) are required
• Ideally, initial experience with data security and data protection regulations
• Experience in validation of laboratory methods and computer-based systems is an advantage
• Independent, analytical and structured working style combined with a high level of responsibility and reliability
• Strong communication skills, team spirit, flexibility and hands-on mentality
• Fluency in written and spoken German and English
• Confident use of electronic data systems, standard office tools and digital document control systems

What they Offer

• A high-autonomy key role with substantial impact, combining strategic and operational responsibilities in quality and regulatory affairs
• A dynamic, collaborative and purpose-driven work environment within an innovative medtech company
• A permanent part-time position (60%) with a competitive salary package
• Flexible working arrangements with a combination of on-site presence in Munich and home-office options