MedTech Regulatory Verifier (EU MDR/IVDR, Swiss MepV/IvDV)

LHH Recruitment Solutions; Zug; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

LHH Recruitment Solutions seeks an experienced Verification & Compliance Specialist to join the Regulatory Affairs team on a 6‑month contract in Rotkreuz, Switzerland. You will verify third‑party medical devices and IVDs for Swiss market compliance under EU MDR/IVDR and Swiss MepV/IvDV.

The ideal candidate holds a degree in Medical Engineering, Life Sciences, or Industrial Engineering and has 3+ years in Regulatory Affairs or Quality Management within MedTech or IVD.

Qualifikationen

• Regulatory expertise in medical devices and IVDR/MDR
• Experience in regulatory verification and DoC review
• Strong documentation review and interpretation abilities
• Bilingual German/English communication skills preferred

Aufgaben

• Regulatory Verification: review and assess technical documentation, DoCs, CE certificates, and labeling for Swiss and EU compliance.
• Vendor & Partner Management: request and review missing regulatory docs, evidence of compliance, and quality agreements.
• PRRC Support: advise on approval/restriction of third‑party products for Swiss market and support PRRC decisions.
• Operational Regulatory Support: assist day‑to‑day regulatory tasks and respond to supplier inquiries.

Kenntnisse

Regulatory expertise

Quality management

Analytical skills

Attention to detail

German & English

Ausbildung

Medical Engineering degree

Life Sciences degree

Industrial Engineering degree

Jobbeschreibung

LHH Recruitment Solutions seeks an experienced Verification & Compliance Specialist to join the Regulatory Affairs team on a 6‑month contract in Rotkreuz, Switzerland. You will verify third‑party medical devices and IVDs for Swiss market compliance under EU MDR/IVDR and Swiss MepV/IvDV.

The ideal candidate holds a degree in Medical Engineering, Life Sciences, or Industrial Engineering and has 3+ years in Regulatory Affairs or Quality Management within MedTech or IVD.