Group Lead Medical Device/ Product Certification

vor 3 Wochen

Wiener Neustadt, Österreich MedAustron EBG Vollzeit

**EBG MedAustron GmbH** in Wiener Neustadt operates one of the most modern centers for particle therapy and research in Europe. Cancer patients are treated with an innovative form of radiation therapy with protons and carbon ions. In addition to cancer treatment the facility is also used for translational research.

**Contribute to the future of the Technology Business Unit in your new role as**

**Group Lead Medical Device/Product Certification (f/m/x)**:
**Full-time (40 hours weekly) / Start date: 01.01.2025**:
**Challenges** you conquer**:

- Define and continuously improve design and development processes to meet Medical Device Regulation (MDR) requirements, ensuring compliance in the product realization process
- Align closely with Quality Management (QM) to ensure the company meets all MDR obligations as a certified medical device manufacturer
- Lead the safety architecture design for machines and accessories, ensuring compliance with safety standards
- Oversee system architecture, including system, hardware, and software components, ensuring alignment with regulatory and safety guidelines
- Manage risk assessment and mitigation strategies to ensure patient safety and product reliability
- Lead test management efforts to ensure compliance with regulatory testing and certification
- Own and manage the change management process to ensure timely and compliant product updates
- Lead conformity assessments for new and existing products to ensure regulatory compliance
- Develop and improve documentation processes to ensure traceability and compliance with regulatory requirements
- Provide training to experts on regulatory topics, including requirements engineering and risk assessment
- Take responsibility for patient safety, ensuring that the intended use of the therapy system meets all regulatory requirements
- Serve as a consultant to internal experts on standards and norms related to medical devices and product certification
- Coordinate operational tasks with TACHG, TAINCS, and other regulatory teams to ensure smooth collaboration
- Provide on-call support for Operations & Services (OP&S) by coordinating with the Technical Performance & Reliability group as needed

**A background** that impresses**:

- Strong management skills, including organizational competence, delegation, problem-solving, conflict resolution, empathy, and resilience
- Proven leadership experience in managing regulatory teams and processes
- Process-oriented approach with a focus on continuous improvement
- Excellent documentation skills and a commitment to fostering these skills within the team
- Ability to clearly communicate management vision to team members and translate it into actionable steps
- A passion for improving the practical implementation of management strategies on a team and group level

**A unique offer** that inspires**:
Further information on EBG MedAustron GmbH, our benefits and what matters to us

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