Jobid=0fc2cc78d435 (0.1008)
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 company events and meaningful initiatives organized throughout the year
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