Vigilance Specialist

True to the vision “We drive innovation to improve people’s lives”, the Hamilton companies have been providing solutions for the health sector since 1950. We are an innovative pioneer in the fields of ventilators, automated pipetting, sample management and in the development of process sensors.

Hamilton Medical is a leading manufacturer of intelligent ventilators. Whether in ICUs, during emergency rescue transport or an MRI scan – our solutions cover a multitude of patient groups, applications and environments.

Job Description:

Working on worldwide relevant vigilance topics in relation to all medical devices of Hamilton Medical AG in order to monitor and evaluate medical devices on the market in compliance with regulations.

This includes:

• Evaluation of complaints, non-conformities and incidents of Hamilton Medical AG medical devices to trigger documentation into the vigilance system in a timely manner

• Implementation of initial vigilance reports in compliance with reporting obligations and taking into account national and international reporting requirements

• Interaction with national authorities on vigilance reports

• Coordinating corrective and safety measures (FSCA) in the field

• Assisting the vigilance team with the continuous improvement of vigilance processes

• Taking part of the KPI realization

Professional experience & skills desired to have:

• Advanced knowledge of EU-MDR 2017/745, FDA 21CFR803
• Good knowledge about MDSAP requirements and ISO 13485 (IEC 60601 is a plus)
• Minimum 2 years of experience with reporting activities in the field of medical devices
• You are fluent in English and can write documents confidently in English.
• German language is a plus
• Good communication and problem-solving skills
• Willing to be curious and to learn
• Self-responsible, flexible, personal motivation, and analytical
• Ability to set up priorities and acting in a timely manner

How to apply:

Send us your resume at jobs.hce.ro@hamilton-ce.com or via the "Apply" button below.

Obtain more information via telephone +40356 635 056

Only suitable candidates will be contacted for interview. Please note that your resume will be entered in our database and may be used in further recruitment projects.