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DEDentsply Sirona

Complaint & PMS Specialist(m/w/x)

Ballaigues
Vollzeitmit HomeofficeJunior

Overseeing complaint handling workflow and assigning investigations for dental products. 1-3 years post-market surveillance experience required. 25 days annual leave, flexible hours, and subsidized meals.

Anforderungen

  • Bachelor’s degree, Associate degree, or equivalent education/work experience
  • 1-3 years post-market surveillance and complaint management experience
  • English B2 minimum
  • French B2 minimum
  • German knowledge is an asset
  • Advanced Excel skills
  • Confident with Microsoft suite (Word, PowerPoint)
  • Experience with Trackwise or smartsolve is a plus
  • Ability to work autonomously and accurately
  • Great attention to details
  • Strong organizational planning skills
  • Strong analytical skills
  • Results oriented
  • Eligible to work in the country of position

Aufgaben

  • Oversee complaint handling workflow for regulatory compliance and timeliness
  • Assign complaint investigations to Complaint Investigators based on complexity, product, and risk
  • Support product returns and credit note processing
  • Prepare and submit blocking requests for impacted products and platforms
  • Collaborate with Quality, Regulatory, and Supply Chain on blocking decisions
  • Create and maintain pre-HHE and HHE documentation
  • Assess complaint data to identify potential safety or compliance risks
  • Ensure traceability between complaints, investigations, and HHE decisions
  • Prepare and submit vigilance reports (e.g., MIR) in accordance with regulations
  • Coordinate responses to requests from Competent Authorities and Notified Bodies
  • Coordinate follow-up, final, and trend-related vigilance submissions
  • Serve as primary interface with Global CHU for vigilance alignment
  • Support Complaint Supervisor for recall and market action activities
  • Ensure regulatory notifications, execution tracking, and effectiveness monitoring
  • Coordinate recall activities across legal and physical manufacturing sites
  • Perform and maintain PMS and PSUR activities in accordance with MDR and jurisdictional requirements
  • Collect, analyze, and trend post-market data from complaints, vigilance, sales, and other sources
  • Maintain PMS documentation, plans, and reports
  • Support periodic risk evaluations and country-specific PMS requirements
  • Prepare PSC meeting materials, including data extraction, trend analysis, and risk summaries
  • Perform PSC analyses and recommendations
  • Track PSC actions and ensure implementation and follow-up
  • Prepare and maintain complaint, vigilance, and PMS KPIs
  • Perform data extraction and analysis for Regulatory, R&D, Marketing, Quality, and Management
  • Provide structured datasets and interpretations to support decision-making
  • Support audit/inspections as needed

Berufserfahrung

  • 1 - 3 Jahre

Ausbildung

  • Abgeschlossene BerufsausbildungODER
  • Bachelor-Abschluss

Sprachen

  • Englischverhandlungssicher
  • Französischverhandlungssicher
  • DeutschGrundkenntnisse

Tools & Technologien

  • Excel
  • Microsoft Word
  • Microsoft PowerPoint
  • Trackwise
  • smartsolve

Benefits

Flexibles Arbeiten

  • Flexible working hours
  • Hybrid working

Sonstige Vorteile

  • Attractive LPP benefits
  • Comprehensive induction

Gratis oder Vergünstigte Mahlzeiten

  • Subsidized meals

Snacks & Getränke

  • Coffee allowance

Gesundheits- & Fitnessangebote

  • Company sports and leisure activities

Weiterbildungsangebote

  • Further training opportunities
  • LinkedIn Learning access

Mentoring & Coaching

  • Global mentoring and coaching program

Mentale Gesundheitsförderung

  • Global employee assistance program
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Dentsply Sirona 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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