About this role
<h4><strong>Your Mission</strong></h4> <ul> <li><strong>Ensuring Product Safety and Compliance:</strong> Play a key role in safeguarding patient safety and ensuring regulatory compliance across post-market safety- and complaint-related matters throughout the product lifecycle. In this role, you make risk-based decisions in complex situations where sound judgment and regulatory robustness are critical.</li> <li><strong>Managing safety- and complaint-related post-market processes:</strong> Drive safety- and complaint-related assessments in the post-market environment and ensure that relevant cases are documented, assessed, and followed up in a complete, timely, and regulatorily sound manner.</li> <li><strong>Leading Product Safety Cases and Vigilance Activities:</strong> Take ownership of Product Safety Cases, Health Risk Assessments, as well as vigilance and field actions from initiation through closure, ensuring structured and robust cross-functional decision-making every step of the way.</li> <li><strong>Moderating the Product Safety Committee:</strong> Shape effective decision-making by organizing and facilitating the Product Safety Committee, preparing complex topics in a decision-ready manner, and creating a sound basis for action even where data is incomplete or conflicting.</li> <li><strong>Managing Escalations and Authority Communication</strong>: Lead escalations in critical cases, coordinate key internal and external stakeholders, and ensure precise, timely, and audience-appropriate communication with authorities and other relevant parties.</li> <li><strong>Driving Process and Governance Development:</strong> Continuously strengthen safety, complaint, and governance processes, turning individual cases into systematic improvements and increasing the robustness, transparency, and effectiveness of key decision-making and escalation processes.</li> <li><strong>Stakeholder Management and Global Collaboration:</strong> Work closely with global, cross-functional stakeholders and leaders, bringing together technical, regulatory, and organizational perspectives in decision-critical situations to create robust alignment and reliable coordination.</li> <li><strong>Advising and Enabling the Organization:</strong> Act as a trusted partner to specialist functions by translating regulatory requirements and new developments into clear actions, helping the organization respond effectively and early.</li> </ul> <h4><strong>Your Talents</strong></h4> <ul> <li>A successfully completed university degree in a relevant field such as engineering, natural sciences, medical technology, or a comparable discipline</li> <li>Several years of solid experience in product safety, vigilance, complaint management, regulatory affairs, or related governance functions in the post-market environment of medical technology or a similarly regulated industry</li> <li>A strong understanding of global regulatory requirements, combined with practical experience in dealing with authorities, reporting obligations, and escalation-relevant safety or compliance issues</li> <li>The ability to analyze complex and ambiguous topics in a structured way, assess risks clearly and transparently, and derive decision-ready recommendations even under uncertainty</li> <li>Confidence in steering critical cross-functional alignment and decision-making processes, as well as the ability to engage different stakeholders effectively, even in controversial situations</li> <li>Experience in moderating committees, escalations, or sensitive decision-making processes in a way that creates clarity, commitment, and sustainable outcomes</li> <li>The ability to set clear priorities, manage matters reliably, and consistently follow through on decisions, even in situations involving high case complexity, incomplete data, and regulatory sensitivity</li> <li>Very good communication skills in German and English, along with the ability to communicate clearly, precisely, and appropriately for different audiences in technically, regulatorily, and organizationally demanding contexts</li> </ul><h4><b>Your Benefits</b></h4> <ul> <li>Flexible working hours & mobile working: In many areas, working hours and location can be arranged as required</li> <li>30 vacation days and various special payments</li> <li>Further training opportunities: Open in-house seminar program, extensive e-learning offering, professional development courses and much more</li> <li>Corporate benefits and bicycle leasing</li> <li>Subsidy for private pension plan and company health management</li> <li>Various childcare options – at the headquarters in Tuttlingen</li> <li>Health, sports, cultural and leisure activities – offers vary depending on location</li> </ul>