Post-Market Safety & Complaint Governance Manager (m/f/d)

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​