Verification & Compliance Specialist (m/w/d) - Regulatory Affairs

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

We are seeking an experienced Verification & Compliance Specialist (m/w/d) to join a dynamic Regulatory Affairs team on a 6-month contract assignment in Rotkreuz. This is an excellent opportunity for a regulatory expert with strong knowledge of EU MDR/IVDR and Swiss MepV/IvDV regulations to contribute to the assessment and compliance of medical devices and in vitro diagnostic products for the Swiss market.

In this role, you will take responsibility for the independent regulatory verification and assessment of third-party products in accordance with applicable European regulations (EU MDR / EU IVDR) and Swiss regulatory requirements (MepV / IvDV).

The ideal candidate is a qualified professional with a degree in Medical Engineering, Life Sciences, Natural Sciences, or Industrial Engineering. The successful candidate brings at least three years of experience in Regulatory Affairs or Quality Management within the Medical Technology and/or IVD industry. Solid knowledge of EU MDR/IVDR and the Swiss MepV/IvDV regulations is essential, along with hands-on experience in reviewing and verifying third-party regulatory documentation. Excellent German and English language skills complete the profile.

Tasks & Responsibilities:

• Regulatory Verification: Independently review and assess technical documentation, Declarations of Conformity (DoC), CE certificates, and labeling of third-party medical devices and in vitro diagnostic products. Verify compliance of product labeling with Swiss Authorized Representative (CH-REP) and importer requirements in accordance with the Swiss Medical Devices Ordinance (MepV) and In Vitro Diagnostic Medical Devices Ordinance (IvDV).
• Vendor & Partner Management: Communicate with suppliers and business partners to request, review, and clarify missing regulatory documentation, evidence of compliance, and quality agreements.
• PRRC Support: Prepare recommendations regarding the approval or restriction of third-party products for placement on the Swiss market and support the Person Responsible for Regulatory Compliance (PRRC) in related decision-making.
• Operational Regulatory Support (as needed): Provide support for day-to-day regulatory activities, including responding to supplier inquiries, reviewing documentation, and assisting with other regulatory tasks as required (non-exhaustive list).

Your profile:

• Completed degree in Medical Engineering, Life Sciences, Industrial Engineering, or a comparable qualification.
• Regulatory expertise: Proven professional experience of 3+ years in Regulatory Affairs and/or Quality Management within the Medical Device (MedTech) or In Vitro Diagnostics (IVD) industry.
• Strong knowledge of Swiss regulatory requirements, with a focus on:
• Swiss In Vitro Diagnostic Devices Ordinance (IvDO)
• Swiss Medical Devices Ordinance (MedDO)
• Experience with third-party processes: Hands-on experience in auditing, reviewing, approving, or verifying supplier and third-party documentation.
• Strong analytical and problem-solving skills, with a high level of attention to detail and a structured approach to work.
• Fluent German and English skills, both written and spoken.

General Information:

• Start Date: ASAP
• Latest Possible Start Date: November 1, 2026
• Planned Assignment Duration: 6 months
• Work Location: Rotkreuz, Switzerland
• Workload: 80-100%
• Remote Work / Home Office: No

This is a 6-month onsite contract opportunity in Rotkreuz within the Regulatory Affairs team, requiring an experienced professional with strong expertise in EU MDR/IVDR and Swiss MepV/IvDV regulations, available to start as soon as possible.