MedTech Regulatory Verification & Compliance Specialist

Actalent; Risch-Rotkreuz; Vor Ort; CHF 90.000 - 140.000; Teilzeit

Zusammenfassung

Actalent is seeking a Detection & Compliance Specialist in Rotkreuz, Switzerland, to oversee regulatory verification and assessment of third-party medical devices and in-vitro diagnostics under EU-MDR/EU-IVDR and Swiss regulations (MepV/IvDV).

You will verify DoCs, CE certificates, labeling, and CH-REP obligations, while coordinating with suppliers and supporting PRRC decisions. Proficiency in German and English is essential.

Qualifikationen

• Regulatory affairs experience in Medtech/IVD
• Hands-on auditing of supplier and third-party documentation
• Experience with IvDV and MepV regulatory frameworks
• Strong documentation review and labeling compliance
• Fluent in German and English, both written and spoken.

Aufgaben

• Regulatory verification: evaluate technical documentation, DoCs, CE certificates and markings for 3rd party devices and IVDs; verify CH-REP and importer labeling per MepV/IvDV.
• Vendor & Partner Management: liaise with suppliers to request and clarify regulatory docs and quality agreements.
• PRRC support: prepare recommendations for approval or rejection of third-party products for the Swiss market.
• Operational support in regulatory affairs as needed (supplier inquiries, document review).

Kenntnisse

Regulatory Affairs

Quality Management

Medtech/IVD

Auditing

Documentation Review

German

English

Ausbildung

Completed studies in medical technology or related field

Jobbeschreibung

Actalent is seeking a Detection & Compliance Specialist in Rotkreuz, Switzerland, to oversee regulatory verification and assessment of third-party medical devices and in-vitro diagnostics under EU-MDR/EU-IVDR and Swiss regulations (MepV/IvDV).

You will verify DoCs, CE certificates, labeling, and CH-REP obligations, while coordinating with suppliers and supporting PRRC decisions. Proficiency in German and English is essential.