Head of Regulatory Affairs (f/m/d) - Automated Infusion Systems

B. Braun Group; Deutschland; Hybrid; EUR 100.000 - 125.000; Vollzeit

Zusammenfassung

A leading medical technology firm in Germany is seeking a Head of Regulatory Affairs to develop global strategies for intelligent infusion systems. This role involves leading regulatory activities, collaborating with global teams, and shaping approval strategies. The ideal candidate will have a degree in a technical field, extensive experience in medical device approvals, and strong German and English skills. The position offers flexibility with mobile working options and impactful benefits.

Leistungen

Company pension plan

Job bike

Holiday childcare

Qualifikationen

• Several years of experience in the approval of active medical devices, ideally in international markets.
• In-depth knowledge of relevant regulations, norms, and standards.
• Passion for leadership, communication, and collaboration.

Aufgaben

• Develop the global regulatory strategy for intelligent infusion systems.
• Lead regulatory activities throughout the entire product lifecycle.
• Collaborate with global teams and international partners.

Kenntnisse

Leadership and team development

Regulatory strategy development

Communication

Collaboration across borders

Knowledge of regulations

Proficiency in German

Proficiency in English

Ausbildung

Completed degree in a technical or scientific field

Jobbeschreibung

Overview

B. Braun Melsungen AG
Job Posting Location: Melsungen, Hessen, Germany
Functional Area: Regulatory Affairs
Working Model: Hybrid
Requisition ID: 2601

At B. Braun, it's about more than just medical technology. It's about responsibility, progress, and impact - and about the vision of making healthcare safer, smarter, and more accessible worldwide. In the Center of Excellence "Automated Infusion Systems," we are shaping the future of intelligent infusion pumps - connected, compliant, and increasingly AI-driven. Our solutions set new standards for patient safety and clinical efficiency - globally. Regulatory Affairs at B. Braun is far more than compliance - it's strategic co-creation. As Head of Regulatory Affairs (f/m/d), you will bring innovations safely and swiftly to market, shape global approval strategies, and act as a driving force for technologies that save lives around the world. This position is based in Melsungen and offers the possibility of mobile working 1-2 days per week.

...

Your Impact - A Leadership Role with Global Reach

• Shape strategy: You develop and take responsibility for the global regulatory strategy for our intelligent infusion systems - with high international visibility and influence
• Manage lifecycle: You lead regulatory activities throughout the entire product lifecycle - from concept to global application
• Leverage networks: You collaborate closely with global teams and international partners - across continents, in a dynamic and interdisciplinary environment
• Build bridges: You are the central contact for authorities, partners, and internal stakeholders - clear, transparent, and solution-oriented
• Drive innovation: You integrate regulatory requirements early in development and promote the use of AI in Regulatory Affairs - for faster processes and new standards
• Live leadership: You inspire, lead, and develop a diverse, high-performing team - with empathy, courage, and vision

What You Should Bring

• A completed degree in a technical or scientific field
• Several years of experience in the approval of active medical devices - ideally in international markets such as the EU and USA
• In-depth knowledge of relevant regulations, norms, and standards
• Excellent German and English skills, both written and spoken
• Passion for leadership, communication, and collaboration - even across borders
• Openness to new technologies and digital solutions, especially in the field of AI
• Willingness to be regularly on-site in Melsungen - because real collaboration thrives on personal exchange

What Awaits You

• A meaningful role with significant impact on global health
• A respectful work environment with room for your ideas and personal development
• Flexible work models (e.g. mobile working, part-time, job sharing)
• Attractive benefits such as company pension plan, job bike, holiday childcare, and much more
• A strong network within an internationally operating family-owned company