Dein persönlicher KI-Karriere-Agent
Complaint & PMS Specialist(m/w/x)
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
- Englisch – verhandlungssicher
- Französisch – verhandlungssicher
- Deutsch – Grundkenntnisse
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
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Complaint & PMS Specialist(m/w/x)
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
- Englisch – verhandlungssicher
- Französisch – verhandlungssicher
- Deutsch – Grundkenntnisse
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
Über das Unternehmen
Dentsply Sirona
Branche
Healthcare
Beschreibung
Das Unternehmen ist der weltweit größte Anbieter von Dentalprodukten und -technologien und unterstützt Zahnärzte und Zahntechniker.
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