Post Market Surveillance Data Analyst (вакансія неактивна)

Due to the growth of our Medical business unit, we are expanding our Clinical Affairs Team, looking for a Post Market Surveillance Data Analyst to join us.

What will you do

— You are responsible for the planning, collection, analysis, and documentation of Post-Market Surveillance activities related to our portfolio of Medical Devices, in close collaboration with other members of the Clinical Affairs Team.

— You perform systematic analyses on data sources such as complaints, adverse events, implant registries, non-conformities, corrective and preventive actions and product recalls. You will summarize data and make conclusions regarding the safety and effectiveness of the medical devices.

— You maintain PMS documentation (plans and reports) and perform updates in a timely manner. You prepare and review reports after data collection, identify trends, provide metrics, and risk information.

— You develop and maintain data pipelines for collecting and processing PMS data. You optimize and enhance current data collection architecture and methods.

— You interact 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 needed.

Your profile

— You 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 in working autonomously in researching and compiling 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 are proficient 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.