Your Mission
* Ensuring Product Safety and Compliance: 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.
* Managing safety- and complaint-related post-market processes: 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.
* Leading Product Safety Cases and Vigilance Activities: 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.
* Moderating the Product Safety Committee: 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.
* Managing Escalations and Authority Communication: 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.
* Driving Process and Governance Development: 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.
* Stakeholder Management and Global Collaboration: 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.
* Advising and Enabling the Organization: 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.
Your Talents
* A successfully completed university degree in a relevant field such as engineering, natural sciences, medical technology, or a comparable discipline
* 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
* A strong understanding of global regulatory requirements, combined with practical experience in dealing with authorities, reporting obligations, and escalation-relevant safety or compliance issues
* 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
* 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
* Experience in moderating committees, escalations, or sensitive decision-making processes in a way that creates clarity, commitment, and sustainable outcomes
* 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
* 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
Your Benefits
* Flexible working hours & mobile working: In many areas, working hours and location can be arranged as required
* 30 vacation days and various special payments
* Further training opportunities: Open in-house seminar program, extensive e-learning offering, professional development courses and much more
* Corporate benefits and bicycle leasing
* Subsidy for private pension plan and company health management
* Various childcare options – at the headquarters in Tuttlingen
* Health, sports, cultural and leisure activities – offers vary depending on location