Medical Device – Post Market Surveillance Specialist – 6118 URA

Our client is a leading Medical Technology company in Switzerland. It is headquartered in Central Switzerland and has a global network of production sites, subsidiaries and sales partners. For our clients Quality division, we are looking for a technically experienced Post Market Surveillance Specialist for a permanent role to be based in Rapperswil.

Main Responsibilities:

·       Supervision of worldwide relevant vigilance topics in relation to all medical devices of the company to monitor and evaluate medical devices on the market in accordance with regulations

·       Evaluation of complaints and incidents of companies’ medical devices as well as documentation in the vigilance system

·       Carrying out compliant reports in compliance with reporting obligations and taking into account national and international reporting requirements

·       Initiating necessary corrective and safety measures in the event of serious incidents in the field

·       Interaction with national authorities on reports and field action measures

·       Assisting with the continuous improvement of vigilance processes

·       Participation in risk-benefit assessments following serious incidents

·       Interface management with other areas of the organization to gain knowledge and comprehensive inputs for the vigilance tasks.

Qualifications and Experience:

  • Relevant working/residency permit or Swiss/EU-Citizenship required.

·       Successfully completed scientific or technical studies or similar

·       At least 2 years of professional experience in the medical device industry with a focus on vigilance and post-market surveillance

·       Good and practical knowledge of requirements from FDA 21 CFR 803 & 806, MDR 2017/745, ISO 13485. Understanding of IEC 60601 regulations desirable

·       Results oriented, multi-tasker, and quick learner; demonstrated ability to respond to the urgent needs of the team and track record of meeting agreed upon deadlines

·       The ability to work independently as well as a team player

·       Fluency in written and spoken English (knowledge of German is an advantage)

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