Viega
Head of Global QMS I Qualitätsmanagementsystem(m/w/x)
Vollzeit
mit Homeoffice
Senior
Keine Angabe
Attendorn
SG
SGS11 Tage
Global Head of Delivery and Operations(m/w/x)
Vollzeit
Remote
Senior
Keine Angabe
Meinerzhagen
Nejo KI-Zusammenfassung
In this role, you will lead the operational delivery of medical schemes, ensuring compliance and driving excellence across technical teams. Your day-to-day responsibilities will involve managing resources, fostering continuous improvement, and collaborating with regulatory bodies to uphold standards.
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Anforderungen
- •Strong understanding of EU MDR, EU IVDR, UKCA, MDSAP, ISO13485 and MDD
- •Proven leadership in managing cross-functional teams in regulated environments
- •Knowledge of conformity assessment procedures and QMS requirements
- •Excellent interpersonal and stakeholder management skills
- •Strong organizational and change management capabilities
- •Strong commercial understanding of the TIC industry
- •Experience in resource planning
- •Qualification as Lead Auditor or Product Assessor under EU MDR/EU IVDR
- •Qualification as Final Reviewer and Decision Maker under MDR or IVDR
- •Experience in a Notified Body or equivalent regulatory organization
- •Minimum 10 years in the medical device or IVD industry, including design, manufacturing, auditing, or technical documentation assessment
- •At least 5 years senior leadership in a Notified Body managing technical employees
- •Minimum 2 years in revenue-focused leadership roles, including P&L accountability, budget management, and financial reporting
- •Demonstrated success in leading high-performing teams and driving operational efficiency
- •Fluency in English in addition to the local language
- •University degree in medicine, engineering, life sciences, or a related field
Bachelor-Abschluss
Berufserfahrung
10 Jahre
Deine Aufgaben
- •Lead and manage global technical functions for medical schemes
- •Ensure compliance with ISO 13485, MDSAP, UKCA, and EU MDR / EU IVDR requirements
- •Oversee efficient allocation and utilization of technical resources
- •Manage operational technical certification activities and monitor KPIs
- •Develop training and competence management strategies for technical teams
- •Support recruitment, onboarding, and qualification of conformity assessment personnel
- •Drive continuous improvement of technical workflows and IT systems
- •Act as a key interface with regulatory authorities and accreditation bodies
- •Monitor and adapt to regulatory changes and industry trends
- •Manage impartiality and conflict of interest policies across teams
- •Ensure compliance with integrity policies, health & safety standards, and confidentiality
- •Foster a culture of client focus and continuous development within technical teams
- •Collaborate with Commercial & Delivery to align capacity with demand
- •Provide strategic input for designation maintenance and regulatory engagement
- •Offer technical input for commercial business development and bid responses
- •Support budget and KPI visibility for technical operations
Sprachen
Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens SGS 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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