ST
Stryker GmbH & Co KG
2 Tage

Senior RAQA Manager - GSA(m/w/x)

Vollzeit
mit Homeoffice
Senior
Keine Angabe
Duisburg, Dr-Homer-Stryker-Platz 1

You will drive regulatory excellence across the GSA region by leading high-performing teams and ensuring strict compliance. Your day-to-day involves strategic leadership, from managing audits to shaping the regional RAQA mission.

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Anforderungen

  • Expertise in RAQA and post-market surveillance
  • Influential communication and stakeholder representation
  • Collaborative cross-functional leadership
  • Experience building high-performing teams
  • Commitment to continuous process improvement
  • BSc degree in relevant field
  • Master's Degree or equivalent desired
  • RAC preferred
  • 10 years' experience and 5+ years supervisory experience
  • Project management and time management skills
  • Knowledge of MDD, EU MDR, and Quality Systems
  • Technical knowledge of medical device requirements
  • Ability to manage multiple project workloads
  • Ability to lead and develop employees
  • Demonstrated leadership skills
  • Experience with recruiting and hiring talent
  • Demonstrated process improvement skills
  • Management of complex multi-region projects
  • Ability to lead cross-functional teams
  • Organizational influence skills
  • Leadership of technical RAQA activities
  • Originality and ingenuity in assignments
  • Ability to take unreviewed action
  • Clear communication with EMEA stakeholders
  • Ability to lead regulatory agency meetings
  • Preparation of briefings and information documents
  • Advisory skills on RAQA requirements
  • Engagement with regulators on critical matters
  • Ability to create clarity amid complexity
  • Openness to diverse ideas and insights
  • Ability to relate to diverse people
  • Acceptance of scrutiny and feedback
  • Preparation of RAQA reporting metrics
  • High attention to detail
  • Strong IT skills, including Microsoft Office
  • Fluency in English and German
Bachelor-Abschluss
ODER
Master-Abschluss

Berufserfahrung

10 Jahre

Deine Aufgaben

  • Lead RAQA operations across the GSA region
  • Ensure compliance with EU MDR and Swiss MedDO
  • Oversee market access processes and certifications
  • Manage regulatory intelligence and documentation
  • Define KPIs and performance targets
  • Coach and develop regional RAQA teams
  • Manage recruiting and onboarding for the local office
  • Serve as the Swiss Authorized Representative (CH-Rep)
  • Engage with regulators and industry associations
  • Drive continuous improvement and system updates
  • Lead integration of new acquisitions
  • Manage third-party and authority audits
  • Report performance and risks to leadership
  • Act as a regional subject matter expert
  • Collaborate with manufacturing and design divisions
  • Develop and implement new regulatory SOPs

Tools & Technologien

Microsoft Office

Sprachen

Englischverhandlungssicher

Deutschverhandlungssicher

Deine Vorteile

Flexibles Arbeiten

  • Hybrid or onsite work flexibility
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Stryker GmbH & Co KG 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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