Galderma SA
Paralegal – Contract Coordinator(m/w/x)
VollzeitPraktikummit Homeoffice
Lausanne
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
HEHelen of Troy
Regulatory Affairs Coordinator(m/w/x)
Lausanne, Bussigny
Vollzeit, Teilzeitmit HomeofficeJunior
Nejo KI-Zusammenfassung
Maintaining CE mark and compiling regulatory dossiers for consumer products in EMEA. 1-2 years regulatory affairs experience preferred. Flexible hours and work from home policy.
Anforderungen
- Fluent English and French
- University or Engineering degree in science or equivalent
- 1-2 years experience in regulatory affairs (preferred)
- MS Office proficiency
- Mandatory fluency in English
- Authorized to work in Switzerland
- Working knowledge of EN ISO 13485 or ISO 9001
- Working experience of CE marking and compliance
- Working experience of WEEE/REACH/RoHs/CLPs for Medical Device
- Knowledge of Low Voltage Directive / EMC Directive (asset)
Aufgaben
- Ensure regulatory documentation is current and compliant in EMEA
- Maintain CE mark
- Compile and submit regulatory dossiers
- Support timely approvals
- Support portfolio continuity
- Own Technical Documentation for assigned projects under MDR 2017/745
- Prepare change assessment files for Notified Body submissions
- Manage change assessment files for Notified Body submissions
- Lead MDR transition activities for legacy devices
- Collaborate cross-functionally with Product Development
- Collaborate cross-functionally with Marketing
- Collaborate cross-functionally with other teams
- Uphold product compliance
- Draft EU Declarations of Conformity and Compliance
- Maintain EU Declarations of Conformity and Compliance
- Review product labelling for regulatory accuracy
- Review marketing materials for regulatory accuracy
- Monitor Clinical Evaluation documentation
- Support Clinical Evaluation documentation
- Monitor Clinical Evaluation processes
- Support Clinical Evaluation processes
- Assist with product registration in Middle East, Africa, and APO
- Assist with product notification in Middle East, Africa, and APO
- Provide regulatory support aligned with sales demand
- Support assigned product categories
Berufserfahrung
- 1 - 2 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – fließend
- Französisch – verhandlungssicher
Tools & Technologien
- MS Office
- EN ISO 13485
- ISO 9001
- CE marking
- WEEE
- REACH
- RoHs
- CLPs
- Low Voltage Directive
- EMC Directive
Benefits
Flexibles Arbeiten
- Flexible working hours
- Work from home policy
Mitarbeiterrabatte
- Swibeco
- Employee discounts on EMEA products
Modernes Büro
- Modern office
- Collaborative workspaces
Mentale Gesundheitsförderung
- Employee assistance counselling line
Gratis oder Vergünstigte Mahlzeiten
- Lunch and Learns
Mehr Urlaubstage
- Company closure between Christmas and New Year’s
Lockere Unternehmenskultur
- International, diverse, and inclusive environment
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Helen of Troy 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.
Noch nicht perfekt?
- Atracsys
Junior Global Business Developer - Robotics & Computer Assisted Surgery(m/w/x)
Vollzeitmit HomeofficeJuniorPuidoux - Helen of Troy
Customer Service Specialist(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenBussigny - Intuitive
Customer Service Associate (German Speaker)(m/w/x)
Vollzeitmit HomeofficeJuniorAubonne - Galderma SA
Paralegal – Contract Coordinator(m/w/x)
VollzeitPraktikummit HomeofficeLausanne
HEHelen of Troy
Regulatory Affairs Coordinator(m/w/x)
Lausanne, Bussigny
Vollzeit, Teilzeitmit HomeofficeJunior
Nejo KI-Zusammenfassung
Maintaining CE mark and compiling regulatory dossiers for consumer products in EMEA. 1-2 years regulatory affairs experience preferred. Flexible hours and work from home policy.
Anforderungen
- Fluent English and French
- University or Engineering degree in science or equivalent
- 1-2 years experience in regulatory affairs (preferred)
- MS Office proficiency
- Mandatory fluency in English
- Authorized to work in Switzerland
- Working knowledge of EN ISO 13485 or ISO 9001
- Working experience of CE marking and compliance
- Working experience of WEEE/REACH/RoHs/CLPs for Medical Device
- Knowledge of Low Voltage Directive / EMC Directive (asset)
Aufgaben
- Ensure regulatory documentation is current and compliant in EMEA
- Maintain CE mark
- Compile and submit regulatory dossiers
- Support timely approvals
- Support portfolio continuity
- Own Technical Documentation for assigned projects under MDR 2017/745
- Prepare change assessment files for Notified Body submissions
- Manage change assessment files for Notified Body submissions
- Lead MDR transition activities for legacy devices
- Collaborate cross-functionally with Product Development
- Collaborate cross-functionally with Marketing
- Collaborate cross-functionally with other teams
- Uphold product compliance
- Draft EU Declarations of Conformity and Compliance
- Maintain EU Declarations of Conformity and Compliance
- Review product labelling for regulatory accuracy
- Review marketing materials for regulatory accuracy
- Monitor Clinical Evaluation documentation
- Support Clinical Evaluation documentation
- Monitor Clinical Evaluation processes
- Support Clinical Evaluation processes
- Assist with product registration in Middle East, Africa, and APO
- Assist with product notification in Middle East, Africa, and APO
- Provide regulatory support aligned with sales demand
- Support assigned product categories
Berufserfahrung
- 1 - 2 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – fließend
- Französisch – verhandlungssicher
Tools & Technologien
- MS Office
- EN ISO 13485
- ISO 9001
- CE marking
- WEEE
- REACH
- RoHs
- CLPs
- Low Voltage Directive
- EMC Directive
Benefits
Flexibles Arbeiten
- Flexible working hours
- Work from home policy
Mitarbeiterrabatte
- Swibeco
- Employee discounts on EMEA products
Modernes Büro
- Modern office
- Collaborative workspaces
Mentale Gesundheitsförderung
- Employee assistance counselling line
Gratis oder Vergünstigte Mahlzeiten
- Lunch and Learns
Mehr Urlaubstage
- Company closure between Christmas and New Year’s
Lockere Unternehmenskultur
- International, diverse, and inclusive environment
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Helen of Troy 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.
Über das Unternehmen
Helen of Troy
Branche
Manufacturing
Beschreibung
The company is a prominent player in the global consumer products industry, offering diverse career opportunities and renowned brands.
Noch nicht perfekt?
- Galderma SA
Paralegal – Contract Coordinator(m/w/x)
VollzeitPraktikummit HomeofficeLausanne - Atracsys
Junior Global Business Developer - Robotics & Computer Assisted Surgery(m/w/x)
Vollzeitmit HomeofficeJuniorPuidoux - Helen of Troy
Customer Service Specialist(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenBussigny - Intuitive
Customer Service Associate (German Speaker)(m/w/x)
Vollzeitmit HomeofficeJuniorAubonne - Galderma SA
Paralegal – Contract Coordinator(m/w/x)
VollzeitPraktikummit HomeofficeLausanne