Job Description
Responsibilities
Review and verify complaint data to ensure accurate and complete regulatory reportingSubmit mandatory reportable events to European authorities within strict timelines and track all follow up activitiesReview and prepare final responses and closing reportsEnsure compliance with European regulations and internal quality and reporting standardsCollaborate closely with QA Engineers responsible for technical complaint investigationsSupport additional regulatory activities such as recall notifications, and internal/external regulatory requests What you bringBachelor’s degree (HBO) in Engineering, Medical Affairs, Regulatory Affairs or related field1+ years relevant working experienceExcellent oral and written communication skills in EnglishKnowledge of another European language is a plusExperience in Medical Devices, knowledge of Quality Management Syst...