Post-Market Surveillance Data Analyst

KYIV, UKRAINE
SOFTWARE ENGINEERING & RESEARCH
HYBRID
FULL-TIME

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 you will do

  • Plan, 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 team
  • Perform 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 devices
  • Maintain 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 information
  • Develop and maintain data pipelines for collecting and processing PMS data; optimize and enhance current data collection architecture and methods
  • 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 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 contract

  • Kyiv, Ukraine
  • Full-time
  • Hybrid
  • Mid-senior level

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Working at Materialise

Materialise is a dynamic, international high-tech company, founded in 1990 and headquartered in Belgium, with over 2,300 employees worldwide. Materialise’s mission is to innovate for a better and healthier world through its software and hardware infrastructure and in-depth knowledge of additive manufacturing (also known as 3D printing). Our customers are in diverse industries, such as automotive, aerospace, medical, research, and academia.

As a growing company, Materialise is always looking for enthusiastic professionals who want to work in an environment full of revolutionary technology and surrounded by people passionate about their work.

What we offer

Work culture

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