Netherlands, AMERSFOORT
Applied Medical Regulatory Affairs Specialist, Post Market (32 - 40hrs per week) - Applied Medical - Amersfoort Applied Medical
Jobid=0fc2cc78d435 (0.1)
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 - Review and prepare final responses and closing reports - Ensure compliance with European regulations and internal quality and reporting standards - Collaborate closely with QA Engineers responsible for technical complaint investigations - Support additional regulatory activities such as recall notifications, and internal/external regulatory requests
What you bring - Bachelor's degree (HBO) in Engineering, Medical Affairs, Regulatory Affairs or related field - 1+ years relevant working experience - Excellent oral and written communication skills in English - Knowledge of another European language is a plus - Experience in Medical Devices, knowledge of Quality Management System, ISO or CE marking is a plus
What we offer - An international working environment, fueled by respect and a healthy work-life balance tailored to the business and team member's needs - 27 paid vacation days (based on fulltime contract) with option to purchase five additional days - This is mainly an on-site role with hybrid options - Commuting allowance of €0,23/km or full coverage of public transportation costs - A wide variety of internal trainings and development possibilities and a tuition program for external trainings - The opportunity to pro-actively work on your vitality and fitness - State-of-the-art facilities, including green areas, in-house restaurant and gym - Additional benefits, such as:Attractive pension scheme (your contribution at 4%, ours at 12%)€50 net monthly health insurance contributionTwo (paid) days per year dedicated to volunteering activitiesSeveral fun compan...
Impostato 1 giorni fa