Freelancer (m/f/d) – Consultant for Vigilance & Safety / Field Safety Corrective Actions (FSCA)
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61273 Wehrheim, Germany |
Freelance
We are seeking a Freelance Consultant (m/f/d) to support the Vigilance & Safety Team in the organization and execution of global Field Safety Corrective Actions (FSCA). The primary focus of this role is the tracking and documentation of customer feedback from the market in compliance with MDR, ISO 13485, and country-specific regulatory requirements.
Project title: Freelancer (m/f/d) – Consultant for Vigilance & Safety / Field Safety Corrective Actions (FSCA)
Type of employment: Payroll
Industry: Dienstleister MedTech
Skills: Drug Safety / Pharmacovigilance,Medical Devices,Clean room technology GMP/ISO13485
Project start: 12.01.2026
Project duration: 6 months
Location: Flexible (45% onsite, 30% remote)
Workload: 75%
Tasks:
- Reconcile customer reply forms with the Field Safety Notices sent to customers.
- Review incoming feedback for completeness and accuracy.
- Clarify outstanding issues in collaboration with the field service team.
- Provide guidance in the preparation and maintenance of balancing reports.
- Ensure transparent and complete documentation of customer responses within global FSCA processes.
- Contribute to the preparation of regulatory-compliant final documentation.
- Utilize MS Office and SharePoint effectively for documentation and reporting.
- Communicate clearly in both German and English, in writing and verbally.
Qualifications:
- Proven experience in vigilance, post-market surveillance, or quality management for medical devices.
- Solid knowledge of regulatory requirements (MDR, ISO 13485).
- Strong proficiency in MS Office and SharePoint.
- Excellent communication skills in German and English (spoken and written).
- Ability to work independently and collaboratively with cross-functional teams.
Reference number: 16965
Industry: Dienstleister MedTech
Project start: 12.01.2026
Duration: 6 months
Employment type: Freelance
Contact
Tünde Verebélyi