Quality Manager in Regulatory Affairs (f/m/d)

Vara; Berlin; Hybrid; EUR 70.000 - 90.000; Vollzeit

Benefits dieser Stelle

Flexible work arrangements

Regular development talks

Team events and offsites

Zusammenfassung

A leading healthcare technology company in Berlin seeks a Quality Manager in Regulatory Affairs. The role involves overseeing Quality Management Systems in compliance with ISO 13485 and providing regulatory support. Ideal candidates should have over 4 years of experience in the medical device industry and familiarity with regulatory submissions. The company offers a flexible work environment and opportunities for personal development, emphasizing a collaborative culture and commitment to diversity.

Qualifikationen

• Minimum 2 years of experience managing quality management systems.
• 4+ years of experience in Quality Management within the medical device industry.
• Strong knowledge of CAPA, Management Reviews, and risk management.

Aufgaben

• Lead and maintain the QMS in accordance with ISO 13485 standards.
• Ensure safety and compliance of QMS processes.
• Manage internal and external audits for regulatory compliance.

Kenntnisse

Quality Management Systems

Regulatory Compliance

Auditing

Data Privacy

Stakeholder Engagement

Ausbildung

Higher education degree (PhD, BA, MA)

Tools

ISO 13485

ISO 14971

GDPR

Jobbeschreibung

About the Role

As Quality Manager in Regulatory Affairs, you will be responsible for maintaining and continuously improving the company’s Quality Management System (QMS), ensuring compliance with ISO 13485 and applicable regulatory requirements. You will coordinate updates to key SOPs and processes, support internal audits, data privacy, and IT security, and act as the person responsible for regulatory compliance in accordance with MDR. You will also provide guidance and support to employees and stakeholders on quality and compliance issues.

Key Responsibilities

• Quality Management System (QMS) – Lead and maintain the QMS in accordance with ISO 13485 standards.
• Quality Management System (QMS) – Ensure safety and compliance of our QMS processes as the Person responsible for Regulatory Compliance.
• Quality Management System (QMS) – Provide training and support to staff on QMS processes, regulatory requirements, and best practices.
• Quality Management System (QMS) – Prepare for management reviews and support process owners in SOP management.
• Audits and Compliance – Manage internal and external audits to ensure compliance with regulatory requirements.
• Audits and Compliance – Drive continuous improvement initiatives within the organization.
• IT Security – Support IT security and employee training activities related to the QMS.
• Stakeholder Engagement – Act as an in-house quality and regulatory expert, advising and supporting internal and external stakeholders.
• Stakeholder Engagement – Collaborate with cross-functional teams to ensure regulatory and quality compliance throughout the product lifecycle.

Your profile

Requirements:

• Higher education degree (PhD, BA, MA) and two years of experience managing quality management systems
• Proven experience in Quality Management within medical device industry, preferably in SaMD/AIaMD (4+ years)
• Strong knowledge of QMS, CAPA, Management Reviews, and risk management (esp. 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 ISO 27001, ISO 9001 as a plus)
• Experience in cybersecurity, 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)

What we offer

Flexible Work & Team Spirit

Whether from home or at our Berlin office, you’re free to shape your workday in the way that suits you best. We believe the best ideas come from collaboration, which is why we actively foster team spirit through regular get-togethers, offsites, and team events.

We regularly benchmark salaries within the tech and healthcare sectors to ensure that your work is recognized and fairly rewarded.

Work at the Merantix AI Campus

Join us at the Merantix AI Campus – the heart of Berlin’s AI scene. Connect with inspiring people, innovative startups, and be part of a community that thrives on creativity and knowledge-sharing.

Your Growth, Our Priority

Your personal and professional development matters to us. You’ll work on exciting projects and have regular development talks with your leads to help shape your career path and reach your goals.

About us

We stand for an open, diverse working environment and are actively committed to equal opportunities. We welcome all applications, regardless of ethnic origin, skin colour, religion, gender, sexual orientation, age, nationality, marital status, disability or gender identity.

We especially encourage people from groups that are underrepresented in the tech industry to apply.

We are also happy to support you throughout the immigration and visa application process.