What you will doPlan, collect, analyze, and document Post-Market Surveillance activities related to our portfolio of medical devices in close collaboration with other members of the Clinical Affairs teamPerform systematic analyses on data sources such as complaints, adverse events, implant registries, non-conformities, corrective and preventive actions, and product recalls; summarize data and make conclusions regarding the safety and effectiveness of the medical devicesMaintain PMS documentation
What you will doPlan, collect, analyze, and document Post-Market Surveillance activities related to our portfolio of medical devices in close collaboration with other members of the Clinical Affairs teamPerform systematic analyses on data sources such as complaints, adverse events, implant registries, non-conformities, corrective and preventive actions, and product recalls; summarize data and make conclusions regarding the safety and effectiveness of the medical devicesMaintain PMS documentation (plans and reports) and perform updates in a timely manner; prepare and review reports after data collection, identify trends, and provide metrics and risk informationDevelop and maintain data pipelines for collecting and processing PMS data; optimize and enhance current data collection architecture and methodsInteract with internal parties (Clinical Affairs, Risk Management, R&D, Regulatory Affairs, Marketing, Product Management, Quality Management) to close the loop with clinical evaluation and post-market surveillance and help drive action and improvement where neededYour profileYou have an academic degree in (life) sciences or prior relevant experience.You like to process and analyze sets of data. You are proficient with data analysis tools such as Microsoft Excel. You have no problem working autonomously to research and compile data through internal and external systems.Knowledge or prior experience in improving or automating data collection processes is a plus.You are proficient with Microsoft Word and in English writing. Prior experience in technical or medical writing is a plus.You can easily collaborate with stakeholders from different countries and cultural backgrounds.You have basic knowledge of human anatomy and physiology to help you understand clinical aspects/conditions related to the medical devices you will work on.Knowledge of medical device regulations and standards such as ISO13485 and EU MDR is a plus, but not required.Location and type of contractKyiv, UkraineFull-timeHybridMid-senior level Show more Show less Посадовий рівень Старший середній рівень Тип зайнятості Повний робочий день Посадові обов’язки Дослідження Галузі Розробка програмного забезпечення і Послуги друку