Complaint and Post Market Surveillance Specialist

Poste a pourvoir : Complaint and Post Market Surveillance Specialist -- Ballaigues -- Dentsply Sirona. Dentsply Sirona cherche un Spécialiste des plaintes et de la surveillance post-commercialisation. Rejoignez un environnement dynamique et innovant.

TACHES

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Gérer la surveillance post-commercialisation et les rapports réglementaires. •
Assurer le suivi des plaintes et coordonner les enquêtes nécessaires. •
Analyser les données pour identifier les tendances et risques potentiels.



COMPETENCES



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Diplôme de niveau Bac+2 minimum avec 1-3 ans d'expérience en dispositifs médicaux. •
Excellentes



COMPETENCES


en gestion des plaintes et conformité. •
Maîtrise des outils Microsoft et analyse de données. Requistion ID
: 82935
Dentsply Sirona is the world's largest manufacturer of professional dental products and technologies, with over a century of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply Sirona's products provide innovative, high-quality, and effective solutions to advance patient care and deliver better and safer dental care. Dentsply Sirona's headquarter is located in Charlotte, North Carolina. The company's shares are listed in the United States on NASDAQ under the symbol XRAY. dentsplysirona. com
for more information about Dentsply Sirona and its products. The Complaint & PMS Specialist is responsible for
post-market surveillance, product surveillance governance, and regulatory reporting/Vigilance
for medical devices. This role owns
blocking requests, HHE activities, recall execution, vigilance reporting, PMS/PSUR activities, PSC governance, KPIs, and data extraction
, and assigns complaint investigations to Complaint Investigators as appropriate. The Complaint and PMS Specialist support the team regarding complaint and PMS activities in accordance with company guidelines, regulatory



REQUIREMENTS


and standard ISO 13485, European Regulation (MDR), FDA 21 CFR part 820-803 (QMSR). Complaint Oversight & Assignment (15%)

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Oversee complaint handling workflow to ensure regulatory compliance and timeliness in collaboration with Global Complaint Handling Unit (CHU). •
Assign complaint investigations to Complaint Investigators based on complexity, product, and risk. •
Support product returns and credit notes if applicable. •
Support Complaint investigator as per business need. Blocking Requests (5%)

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Prepare and submit blocking requests for impacted products and platforms. •
Support blocking decisions with Quality, Regulatory, and Supply Chain. Health Hazard Evaluation (HHE) (5%)

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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. Vigilance & Regulatory Reporting (15%)

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Prepare and submit
vigilance reports
(e. , MIR) in accordance with applicable regulations. •
Coordinate in collaboration with Complaint Supervisor responses to
requests from Competent Authorities and Notified Bodies. •
Coordinate follow-up, final, and trend-related vigilance sub



MISSIONS


. •
Serve as primary interface with Global CHU for vigilance alignment. Recall & Market Actions (5%)

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Support the 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. Post-Market Surveillance (PMS / PSUR) (10%)

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Perform and maintain PMS and PSUR activities in accordance with MDR



REQUIREMENTS


and applicable jurisdictions (e. UK, Canada, China. )

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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


. Product Surveillance Committee (PSC) (10%)

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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. KPIs & Data Extraction (35%)

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Prepare and maintain
complaint, vigilance, and PMS KPIs. •
Perform
data extraction and analysis
for Regulatory, R&D, Marketing, Quality, and Management as applicable. •
Provide structured datasets and interpretations to support decision-making. •
Support audit/inspections as per business need. Depending on the needs of the company, the employee may be entrusted with and asked to perform other tasks related to his/her competence. •
Complaint & Post Market surveillance (PMS) Specialist
The Complaint & PMS Specialist is responsible forpost-market surveillance, product surveillance governance, and regulatory reporting/Vigilancefor medical devices. This role ownsblocking requests, HHE activities, recall execution, vigilance reporting, PMS/PSUR activities, PSC governance, KPIs, and data extraction, and assigns complaint investigations to Complaint Investigators as appropriate. Responsibilities

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Manage complaint handling workflows, ensuring regulatory compliance and prompt resolution in partnership with the Global Complaint Handling Unit (CHU). •
Assign complaint investigations to appropriate Complaint Investigators, considering complexity, product, and associated risks. •
Support product returns and credit note processing where necessary. •
Prepare and submit blocking requests for affected products and platforms, collaborating with Quality, Regulatory, and Supply Chain teams on decisions. •
Create and maintain Health Hazard Evaluation (HHE) documentation, assess complaint data for safety or compliance risks, and ensure traceability between complaints, investigations, and HHE outcomes. •
Prepare and submit vigilance reports (e. , MIRs) in line with regulatory



REQUIREMENTS


, coordinate responses to Competent Authorities and Notified Bodies, and serve as the main contact with Global CHU for vigilance matters. •
Support recall and market action activities under the guidance of the Complaint Supervisor, ensuring regulatory notifications, tracking execution, and monitoring effectiveness across manufacturing sites. •
Conduct and maintain Post-Market Surveillance (PMS) and Periodic Safety Update Reports (PSUR) as per MDR and jurisdictional



REQUIREMENTS


, including data collection, analysis, and documentation. •
Prepare materials for Product Surveillance Committee (PSC) meetings, perform PSC analyses and recommendations, and track implementation of PSC actions. •
Prepare and maintain KPIs related to complaints, vigilance, and PMS; perform data extraction and analysis for Regulatory, R&D, Marketing, Quality, and Management; provide datasets to inform decision-making and support audits as needed. Profile requested

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Educated to a Bachelor's degree, Associate degree or an equivalent combination of education and work experience

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1-3 years experience in post-market surveillance and complaint management of medical devices (complaint evaluation/analysis / safety assessment / medical device reporting/ compliance)

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English & French B2 minimum - German knowledge is an asset

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Excel advanced - confident with Microsoft suite (Word, PowerPoint. )

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Experience with software such as Trackwise, smartsolve a plus

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Ability to work autonomously and accurately - great attention to details

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Strong organisational planning and analytical skills -

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Results oriented
As part of our team, you'll experience the spirit of an international and innovative market leader in the dental industry. Besides an attractive remuneration package, you will also be eligible for a variety of employee benefits, such as:
25 days' annual leave (full time basis) and flexible working hours, with the option of hybrid working, so that you can achieve an optimum work-life balance. Attractive LPP benefits and you can enjoy subsidized meals in our company restaurant as well as a coffee allowance and boost your health and wellbeing by taking part in company sports and leisure activities. We attach great importance to your development: a comprehensive induction, further training opportunities and access to LinkedIn Learning are available to you. Take advantage of personal and professional development opportunities through our global mentoring and coaching program. In addition,

WE OFFER

an extensive, global employee assistance program that provides a wide range of benefits. Equal Opportunity Employer:
Dentsply Sirona is an Equal Opportunity Employer. All qualified applicants will be considered without unlawful discrimination or regard for race, color, religion, sex, sexual orientation, sexual or gender identity, national or ethnic origin, age, marital status, disability, genetic factors, military and veteran status, or any other characteristics protected by applicable local law. Eligibility:
All successful applicants must be eligible to work in the country the position is based. Assistance:
If you need assistance with completing the online application due to a disability, please send an accommodation request to
Write an email. Agencies:
Please note that Dentsply Sirona does not accept or respond to unsolicited requests or applications submitted by Recruitment Agencies/ Search Firms. Notice on Fraudulent Job Offers:
Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information:
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