Vigilance Specialist - Zurich, Zurich
vor 12 Stunden
Jobbeschreibung
A globally recognized manufacturer in the medical device industry is looking to strengthen its Post‑Market Surveillance & Vigilance function. The company develops advanced technologies used across intensive care, emergency transport, and other critical healthcare environments, supporting a wide range of clinical applications.
How you will contribute:
- Conduct reportability assessments for incoming post‑market events
- Prepare initial vigilance reports within required timelines
- Take responsibility for meeting deadlines and complying with regulatory timeframes
- Create final reports based on completed investigations
- Communicate effectively with internal teams and external partners
- Manage communication with health authorities, including cases of higher complexity
- Prepare overviews and summaries of reported events for regulatory bodies
- Generate statistics for the annual management review
- Participate in audits and inspections as needed
- Assist in process improvement projects across the PMS/Quality areas
- Support and coach team members in their daily tasks
What you bring:
- Strong experience in Post‑Market Surveillance, specifically in vigilance reporting (assessment, initial reporting, follow‑up, final reporting)
- Ability to communicate confidently with competent authorities
- A critical mindset with the ability to challenge data quality and ensure data integrity
- Familiarity with complaint handling, CAPA, and related quality system processes
- Solid knowledge of medical device regulations (EU‑MDR 2017/745, FDA 21 CFR 803, MDSAP)
- Fluency in English and German
- Strong communication and problem‑solving skills
- A structured, detail‑oriented approach to documentation
- Curiosity, willingness to learn, and a proactive attitude
- Ability to prioritize effectively and work within defined timelines
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