Pre - Sales & Compliance Specialist overseeing proposals and compliance processes at Zalaris. Responsible for contract management, documentation, and collaboration with sales teams.
About the role
- Quality Manager in Regulatory Affairs ensuring compliance with ISO 13485 standards and managing the company's Quality Management System. Provide guidance on quality and compliance issues in AI-powered breast cancer detection.
Responsibilities
- Maintain and continuously improve the company’s Quality Management System (QMS)
- Ensure compliance with ISO 13485 and applicable regulatory requirements
- Coordinate updates to key SOPs and processes
- Support internal audits, data privacy, and IT security
- Act as the person responsible for regulatory compliance in accordance with MDR
- Provide guidance and support to employees and stakeholders on quality and compliance issues
Requirements
- Higher education degree (PhD, BA, MA)
- Minimum 2 years’ experience managing quality management systems
- Strong communication skills in English and German
- Proven experience in Quality Management within the medical device industry, preferably in SaMD/AIaMD (4+ years)
- Solid knowledge of QMS, CAPA, Management Reviews, and risk management (especially ISO 14971)
- Familiarity with AI/ML validation, software development workflows, and lifecycle management
- Experience with regulatory submissions and audits (MDR, IVDR, MDSAP, FDA SaMD Guidance, IMDRF)
- Nice to have: Certified Auditor for ISO 13485 (additional certifications such as ISO 27001, ISO 9001 are a plus)
- Experience in cybersecurity and data privacy (GDPR, HIPAA, IEC 81001, IEC 27001)
- Understanding of AI/ML-specific regulatory requirements (e.g., GMLP, EU AI Act)
- Prior experience in startup or scale-up environments
- Fluent in German (minimum B2 level)
Benefits
- Flexible work arrangements & strong team spirit
- Work at the Merantix AI Campus
- Fair & competitive compensation
- A range of benefits tailored to your life
- Focus on your professional growth
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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