PPT Pharma Process Technology GmbH
Standortleiter Quality / Compliance(m/w/x)
Vollzeit
mit Homeoffice
Keine Angabe
Marburg
SI
Siemens Healthineers3 Stunden
Head of Medical Operations - Diagnostics(m/w/x)
Vollzeit
mit Homeoffice
Senior
Keine Angabe
Marburg
Nejo KI-Zusammenfassung
In this role, you will lead clinical validation and medical operations for diagnostics, ensuring effective execution and risk management while supporting product performance and compliance in the market.
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Anforderungen
- •University degree in medical engineering
- •Senior leadership experience in clinical validation, clinical operations, or medical operations
- •Experience in IVD diagnostics
- •Experience in medical devices
- •Accountability for global clinical validation delivery
- •Ability to translate medical and clinical strategies into regulatory validation plans
- •Experience in supporting products post-launch
- •Strong track record in matrixed, global IVD or medical device organizations
- •Deep understanding of global clinical validation and regulatory pathways
- •Experience in supporting regulatory submissions and interactions
- •Strong grounding in post-market surveillance, vigilance, and risk-benefit assessment
- •Fluent English language skills (verbal & written)
- •Ownership of outcomes and delivery commitments
- •Collaborative authority with decisiveness
- •Hands-on, execution-focused leadership style
- •Strong lifecycle and systems thinking
- •Driving rigor and predictability without slowing innovation
- •Flexibility for international travel of around 40%
Bachelor-Abschluss
Berufserfahrung
ca. 4 – 6 Jahre
Deine Aufgaben
- •Translate medical value propositions into clinical validation strategies
- •Lead global planning and execution of registrational and validation studies
- •Ensure adherence to timelines, quality standards, and resource efficiency
- •Establish clear delivery commitments with core teams and functions
- •Proactively identify and mitigate execution and delivery risks
- •Own the medical operations framework for post-launch clinical support
- •Ensure rapid response to clinical inquiries and performance issues
- •Maintain continuity between pre-market assumptions and real-world performance
- •Enable scalable, globally deployable product support models
- •Strengthen lifecycle medical risk management aligned with regulatory and quality systems
- •Oversee clinical aspects of post-market surveillance and vigilance
- •Lead cross-functional responses to significant clinical or medical risks
- •Integrate post-market learnings into validation strategies and product improvements
- •Exercise decision authority over execution approaches and operational trade-offs
- •Align validation priorities with Business Lines and enterprise strategy
- •Partner closely with Regulatory Affairs, Quality, Medical Sciences, and Strategy teams
- •Act as a visible executive role model for accountability and collaboration
- •Build a scalable, cost-effective clinical validation and medical operations system
- •Improve execution maturity, predictability, and transparency
- •Develop global talent and leadership pipelines
- •Establish metrics and governance to reinforce ownership and delivery focus
Sprachen
Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Siemens Healthineers erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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