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

• 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.

Qualifications

• 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.

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.
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