Quality Manager – Regulatory Affairs & QMS (m/f/d)

In this role, you will take ownership of the company’s Quality Management System and act as the Person Responsible for Regulatory Compliance (PRRC). You will work closely with cross-functional teams to ensure regulatory compliance, product safety, and continuous quality improvement across the entire product lifecycle.

Key Responsibilities

Quality Management System (QMS)

• Lead, maintain, and continuously improve the QMS in accordance with ISO 13485
• Act as PRRC, ensuring compliance with EU MDR and applicable regulatory requirements
• Coordinate updates to SOPs, processes, and quality documentation
• Prepare and support management reviews, CAPA activities, and risk management processes
• Provide training and guidance to employees on quality, regulatory, and best-practice topics

Audits & Regulatory Compliance

• Plan, manage, and support internal and external audits
• Support regulatory submissions, inspections, and interactions with authorities
• Drive continuous improvement initiatives across the organization

IT Security & Data Protection

• Support IT security and data protection activities relevant to the QMS
• Contribute to employee awareness and training related to information security

Stakeholder & Cross-Functional Collaboration

• Serve as the internal expert for quality and regulatory topics
• Advise internal and external stakeholders on compliance-related matters
• Collaborate with Product, Engineering, Clinical, and Operations teams to ensure regulatory and quality compliance throughout the product lifecycle

Your Profile

Required Qualifications

• University degree in a relevant field (Bachelor’s, Master’s, or PhD)
• At least 2 years of hands-on experience managing a Quality Management System
• 4+ years of experience in Quality Management within the medical device industry, ideally in Software as a Medical Device (SaMD) / AI-based medical devices
• Strong knowledge of QMS processes, CAPA, Management Reviews, and risk management (ISO 14971)
• Experience with regulatory submissions, audits, and inspections (e.g. MDR, IVDR, MDSAP, FDA SaMD guidance, IMDRF)
• Very good communication skills in English and German

Additional Assets (Nice to Have)

• Certified ISO 13485 auditor (ISO 9001 and/or ISO 27001 are a plus)
• Experience with cybersecurity and data protection frameworks (e.g. GDPR, HIPAA, IEC 81001, ISO 27001)
• Familiarity with AI/ML validation, software development lifecycles, and AI-specific regulations (e.g. GMLP, EU AI Act)
• Background in startup or scale-up environments

What’s Offered

• Flexible working model, including fully remote work within Germany
• Occasional travel required for internal and external audits (approximately 2 weeks per year)
• Competitive salary range aligned with experience (approx. €50,000–€65,000)
• Modern, collaborative work environment within an innovative AI and healthcare ecosystem
• Personal and professional development through challenging projects and regular feedback
• Inclusive and diverse workplace culture with equal opportunity commitment