Associate RA Specialist, Post Market

Applied Medical

Amersfoort, Netherlands

Are you passionate about Medical Devices post market surveillance, and would you like to conduct product analysis and investigations in the laboratory of a Medical Devices manufacturer?

Do you enjoy not knowing beforehand what you will be working on, if there are fixed procedures to follow?

In this hands-on role, you will be responsible for supporting various post market activities within the organization to facilitate regulatory compliance with regional and international laws and regulations. This includes receiving and processing complaints from the field, and ensuring that effective reporting, trending, communication, and correct actions are taken.

To succeed and thrive in a fast-paced environment, you communicate effectively with different stakeholders and are able to prioritize pending tasks to meet deadlines.

Key Responsibilities

Support the Post Market Regulatory Affairs team in Post Market activities, such as vigilance and trend reporting
Conduct analysis and investigations on medical devices
Initiation of customer complaints and regulatory decisions
Collaborate with the Sales teams to acquire additional information to support the complaint and the decisions made as a result
Interact and communicate with internal and external stakeholders with regards to additional information required
Support senior team members in the execution of their tasks
Initiate and support operational projects within the RA department

What you bring

Bachelor’s degree (HBO) in Engineering, or Biotechnology
At least 1 year experience in a product-focused role, for example: product development, product design, product analysis or investigation
Working experience in Medical Devices or a highly regulated industry
Work experience in an international environment
Excellent oral and written communication skills in English
Ability and right to work in the Netherlands
Knowledge of any other European language is a plus

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