Clinical Evidence & Regulatory Manager

Sonova Group; Genf, Stäfa; Hybrid; CHF 120.000 - 160.000; Vollzeit

Zusammenfassung

Sonova Group is seeking a dedicated Clinical Affairs Manager to support clinical evaluation of hearing instrument systems and market access alignment in a regulated environment.

The role requires a master’s or PhD in health sciences or related field, experience with clinical studies, and strong analytical skills. Fluent English is required; German is a plus. This is a hybrid role in Switzerland with cross-functional collaboration across R&D, regulatory, and QA teams.

Qualifikationen

• Masters or PhD in health sciences or related field.
• Experience with clinical studies and data interpretation.
• Knowledge of EU MDR, FDA, GCP, ISO 14155.
• Strong analytical and detail-oriented mindset.
• Fluency in English; German a plus.

Aufgaben

• Support clinical evaluations across the product lifecycle in line with company procedures and global regulations.
• Create and maintain clinical evaluation documentation (CE Plans/Reports, Development Plans, literature search plans).
• Assess device safety, performance and benefit–risk against current standards.
• Collaborate with Clinical Affairs, Regulatory, Quality and Marketing to ensure compliance.

Kenntnisse

Analytical skills

Independent working

Cross-functional collaboration

English fluency

German knowledge (advantage)

Ausbildung

Master's degree or PhD in health sciences or related field

Tools

PubMed

Cochrane Library

Embase

Polarion

Jobbeschreibung

Sonova Group is seeking a dedicated Clinical Affairs Manager to support clinical evaluation of hearing instrument systems and market access alignment in a regulated environment.

The role requires a master’s or PhD in health sciences or related field, experience with clinical studies, and strong analytical skills. Fluent English is required; German is a plus. This is a hybrid role in Switzerland with cross-functional collaboration across R&D, regulatory, and QA teams.