Job Opportunities in Austria

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
• In-depth understanding of regulatory requirements, particularly MDR, with the ability to apply regulations in an efficient, pragmatic way
• 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: