Senior Regulatory & Design Quality Engineer – MedTech

Symbios Orthopédie S.A.; Yverdon-les-Bains; Vor Ort; CHF 130.000 - 170.000; Vollzeit

Zusammenfassung

Symbios Orthopédie S.A. in Yverdon-les-Bains, Switzerland, seeks a Regulatory Affairs Design Quality Engineer. You will lead regulatory interactions, support design and development of medical devices, and ensure compliance with EU MDR and FDA QMSR.

You will manage technical dossiers, change controls, and CAPA within a global regulatory framework. Ideal candidates hold a Master’s degree with 7+ years in the medical device industry, fluent French and English, and strong experience with Competent

Qualifikationen

• Engineer or Master with minimum 7 years in Medical Device
• Strong knowledge of EU-MDR and FDA QMSR
• Experience with interactions with Competent Authorities/Notified Bodies
• Experience in manufacturing change control under EU/US regs
• Knowledge of ISO 14971 risk management and related tools
• Regulatory software knowledge is a plus
• Fluent in French and English; German is a plus

Aufgaben

• Primary regulatory contact with authorities and Notified Bodies for pre- and post-market submissions and audits
• Support engineering in design/control documentation and ensure regulatory compliance
• Maintain and defend technical documentation and 510(k) where applicable
• Ensure QMS processes under regulatory scope are applied and continuously improved
• Interpret and apply medical device regulations (EU MDR, FDA QMSR) in the organization
• Collaborate cross-functionally with Engineering, Operations, Quality, Marketing and Clinical Affairs

Kenntnisse

Regulatory affairs

Quality systems

Risk management

Cross-functional collaboration

Regulatory intelligence

Regulatory reporting

French-English bilingual

Ausbildung

Master's degree

Jobbeschreibung

Symbios Orthopédie S.A. in Yverdon-les-Bains, Switzerland, seeks a Regulatory Affairs Design Quality Engineer. You will lead regulatory interactions, support design and development of medical devices, and ensure compliance with EU MDR and FDA QMSR.

You will manage technical dossiers, change controls, and CAPA within a global regulatory framework. Ideal candidates hold a Master’s degree with 7+ years in the medical device industry, fluent French and English, and strong experience with Competent