Vigilance Specialist - Zurich
vor 1 Tag
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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