Boston Scientific
Public Affairs and Health Economics & Market Access lead(m/w/x)
Vollzeitmit HomeofficeSenior
Solothurn
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
STStryker-Osteonics AG
RAQA Specialist – Regulatory Affairs & Quality Systems(m/w/x)
Biberist
Vollzeitmit HomeofficeBerufserfahren
Nejo KI-Zusammenfassung
Preparing and coordinating Swiss regulatory submissions for medical devices. 2+ years RAQA experience in regulated industry required. Hybrid work, German language proficiency.
Anforderungen
- Bachelor's degree in Engineering, Science, or related field
- 2+ years RAQA experience in regulated industry
- Preferred experience: regulatory submissions/registrations, product registration maintenance, QMS process support, change control documentation, or regulatory compliance activities
- Proficiency in English and German
- Strong communication and collaboration skills
- Knowledge of MDR 2017/745 and Swiss medical device legislation
- Understanding of Swiss market requirements (e.g., CH-REP/Swiss registration concepts)
- Experience with Swiss regulatory tools/systems or comparable registration databases
- Experience with data maintenance activities
- Experience supporting QMS documentation processes
- Confident stakeholder management skills
- Continuous improvement mindset
Aufgaben
- Support product registration and lifecycle maintenance
- Prepare, review, and maintain regulatory documentation
- Coordinate Swiss regulatory submissions and notifications
- Ensure data quality, completeness, and compliance
- Monitor regulatory requirements and assess impacts
- Implement changes to regulatory requirements
- Provide RAQA process support to internal stakeholders
- Guide internal stakeholders on local regulatory requirements
- Support QMS processes and documentation
- Update SOPs and manage records
- Support training initiatives
- Contribute to continuous improvement initiatives
- Support internal and external audits
- Prepare for inspection readiness activities
- Contribute to cross-functional projects
- Strengthen RAQA processes and interfaces
Berufserfahrung
- 2 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- MDR 2017/745
- MedDO
- Swissdamed
Benefits
Flexibles Arbeiten
- Hybrid work
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Stryker-Osteonics AG 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.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Noch nicht perfekt?
- Stryker-Osteonics AGRegional Sales Manager Endoscopy(m/w/x)Vollzeitmit HomeofficeSeniorBiberist
- StrykerLean Specialist - Process Improvement(m/w/x)Vollzeitmit HomeofficeBerufserfahrenSelzach
- GRIFOLS, S.A.Sales & Technical Application Specialist (STAS)(m/w/x)Vollzeitmit HomeofficeJuniorBern, Basel, Solothurn
- BSA - Bobst Mex SATechnical Support Specialist - Maschinen- & Anlagenbau(m/w/x)Vollzeitmit HomeofficeBerufserfahrenGrenchen