Functiebeschrijving
Regulatory Affairs Associate - Post Market Surveillance Applied Medical Amersfoort, Netherlands
Are you organized, adaptable, and energized by working in a fast-paced environment?
Do you pride yourself on communication and collaboration skills, and would you like to join an international and forward-thinking medical devices company?
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 structured but dynamic environment, you communicate effectively with different stakeholders and can prioritize pending tasks to meet deadlines. Key Responsibilities - Review and verify complaint data to ensure accurate and complete regulatory reporting; - Submit mandatory reportable events to European authorities within strict timelines and track all follow up activities; - Collaborate with the other teams to acquire additional information to support the complaint and the decisions made as a result; - Interact and communicate with internal and external stakeholders in order comply with due dates and procedures; - 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 the field of healthcare or engineering, or experience in Regulatory Affairs; - At least 1 year relevant working experience; - Working experience in an international environment; - Excellent oral and written communication skills in English, knowledge of any other European language is a plus; - Ability and right to work in the Netherlands.
Don't forget to mention EuroPharmaJobs when applying.
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