Location: Switzerland - Remote
Salary: Negotiable
We are partnered with one of the largest global medical technology companies in the world. They are advancing the world of health by improving the lives of patients. As a vigilance specialist you will supervise vigilance topics in relation to all medical devices to monitor and evaluate the medical devices on the market in accordance to the regulations.
Responsibilities:
- Participation in risk-benefit assessments after serious incidents
- Interface management in other areas of the organization to initiate necessary corrective measures
- Implementation of rule-compliant reports in compliance with reporting obligation and taking into account national and international reporting requirement
- Initiation of necessary corrective and safety measures in the even of serious incidents in the field
Requirements:
- BSc in a scientific or engineering background
- 3 to 5 years of professional experience in the medical device industry with a focus on vigilance and post-market surveillance
- In-depth knowledge of applicable regulated national and international requirements for vigilance reporting
- Knowledge of FDA, MDR, ISO 13485 and IEC 60601 regulation
- Experience in regulatory affairs/approval of medical device
- Fluent in English and German
