Verification and Compliance Ingegnere (m/f/d) — Coopers Group AG
- Località
- Zug
- Contratto
- contracting
- Pubblicato
- 6 giorni fa
Panoramica
In this role, you will be responsible for the independent regulatory verification and evaluation of third-party products (3rd party products) in relation to the applicable European (EU-MDR / EU- IVDR) and Swiss regulations (MedDO / IvDV).
- In this role, you will be responsible for the independent regulatory verification and evaluation of third-party products (3rd party products) in relation to the applicable European (EU-MDR / EU- IVDR) and Swiss regulations (MedDO / IvDV).
- Regulatory verification: Independent review and evaluation of technical documentation, declarations of conformity (DoC), CE certificates and markings of 3rd party medical devices and in vitro diagnostics, verification of the correct labeling with regard to CH-REP (Swiss Authorized Representative) and importer obligations according to MedDO/IvDO.
- Vendor & Partner Management: Communication with suppliers and partners to demand, review and clarify missing regulatory evidence and quality agreements.
- Life Sciences - Quality Management Contracting Full Time
- As soon as possible/latest start date 1.11.2026 - 6 months Compliance, IVD, Medtech
Responsabilità principali
- Regulatory verification: Independent review and evaluation of technical documentation, declarations of conformity (DoC), CE certificates and markings of 3rd party medical devices and in vitro diagnostics, verification of the correct labeling with regard to CH-REP (Swiss Authorized Representative) and importer obligations according to MedDO/IvDO.
- Vendor & Partner Management: Communication with suppliers and partners to demand, review and clarify missing regulatory evidence and quality agreements.
- PRRC Support: Creation of recommendations for the release or blocking of third-party products for the Swiss market.
- Operational support in the area of regulatory as required: e.g. supplier enquiries, document review (non-exhaustive list) Must Haves:
- Successfully completed studies in the field of medical technology, natural sciences, industrial engineering or a comparable qualification
- Fluent in German and English, both written and spoken
- Regulatory expertise: Demonstrable, several years (3+ years) of professional experience in Regulatory Affairs / Quality Management in the medtech or IVD sector In-depth knowledge
- Focus: Swiss In-vitro Diagnostics Ordinance (IvDV) Swiss Medical Devices Ordinance (MedDO)
- Experience with 3rd party processes: Hands-on experience in auditing, approving or verifying supplier and third-party documentation Job profile Life Sciences Quality Management Zug Contracting Full Time
- As soon as possible/latest start date 1.11.2026
Requisiti principali
- Life Sciences - Quality Management Contracting Full Time
- As soon as possible/latest start date 1.11.2026 - 6 months Compliance, IVD, Medtech
Dettagli ulteriori
- Operational support in the area of regulatory as required: e.g. supplier enquiries, document review (non-exhaustive list)
- Regulatory expertise: Demonstrable, several years (3+ years) of professional experience in Regulatory Affairs / Quality Management in the medtech or IVD sector In-depth knowledge
- Focus: Swiss In-vitro Diagnostics Ordinance (IvDV) Swiss Medical Devices Ordinance (MedDO)
- Experience with 3rd party processes: Hands-on experience in auditing, approving or verifying supplier and third-party documentation Quality Management Compliance, IVD, Medtech
Note e contenuto originale
- Responsibilities:
- Must Haves:
- Regulatory expertise: Demonstrable, several years (3+ years) of professional experience in Regulatory Affairs / Quality Management in the medtech or IVD sector
- In-depth knowledge
- Focus: Swiss In-vitro Diagnostics Ordinance (IvDV)
- Swiss Medical Devices Ordinance (MedDO)
- Experience with 3rd party processes: Hands-on experience in auditing, approving or verifying supplier and third-party documentation
- Job profile
- Life Sciences
- Quality Management
Domande frequenti su questo annuncio
Che stipendio offre Coopers Group AG per questa posizione?
Coopers Group AG indica CHF 78'500 - 119'000 lordi annui per questo ruolo a Zug. Questo è lo stipendio pubblicato nell'annuncio originale (o, quando il datore non specifica una cifra, una stima realistica per ruolo e settore) — il calcolatore di questo sito lo converte nel netto reale una volta applicate imposta da frontaliere e contributi sociali.
È un ruolo a tempo pieno, e che tipo di contratto offre Coopers Group AG?
Questo annuncio è una posizione a tempo pieno. Il tipo di contratto mostrato qui arriva direttamente dall'annuncio originale del datore di lavoro; conferma sempre orario esatto, preavviso e durata del periodo di prova con Coopers Group AG durante il colloquio, perché questi dettagli possono variare anche all'interno della stessa categoria contrattuale.
Serve un permesso da frontaliere per un ruolo nel canton Zugo?
I residenti UE/AELS nella zona di frontiera del paese confinante con il canton Zugo possono richiedere il Permesso G; il datore di lavoro svizzero lo presenta all'ufficio della migrazione di quel canton dopo la firma del contratto. Regole sulla zona di frontiera e tempi di lavorazione variano per paese confinante e canton — verifica i dettagli con l'ufficio della migrazione del canton Zugo o con HR durante il colloquio.
Come mi candido a questa posizione presso Coopers Group AG?
Usa il pulsante "Candidati ora" in questa pagina — rimanda direttamente all'annuncio originale di Coopers Group AG su coopers.ch, quindi la tua candidatura arriva direttamente nel sistema di gestione candidature del datore di lavoro. Frontaliere Ticino non raccoglie né inoltra candidature in proprio.
