Vigilance Specialist

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