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

more-jobs; Zug; Vor Ort; CHF 110.000 - 140.000; Vollzeit

Zusammenfassung

more-jobs is seeking an experienced Verification & Compliance Specialist to join the Regulatory Affairs team on a 6-month onsite contract in Rotkreuz, Switzerland. The role focuses on EU MDR/IVDR and Swiss MepV/IvDV compliance for medical devices and IVDs.

You will review third-party documentation, support PRRC activities, and coordinate with suppliers. Fluent German and English are required, with at least three years in Regulatory Affairs or Quality within MedTech/IVD.

Qualifikationen

• 3+ years in Regulatory Affairs or Quality Management in MedTech/IVD.
• Strong knowledge of EU MDR/IVDR and Swiss MepV/IvDV.
• Experience with third‑party documentation review and verification.

Aufgaben

• Regulatory Verification: review DoC, CE certificates, and labeling for Swiss/European requirements.
• Vendor & Partner Management: request, review, and clarify missing regulatory documents.
• PRRC Support: advise on approval or restrictions for third‑party products.
• Operational Regulatory Support: assist with day‑to‑day regulatory tasks as needed.

Kenntnisse

Regulatory expertise

Documentation review

Supplier management

PRRC support

Analytical thinking

German language

Ausbildung

Degree in Medical Engineering, Life Sciences, Industrial Engineering

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.