EU Post Market Surveillance Specialist

📋 Description

• Evaluates incoming complaint information and maintains the records in the electronic database as
• Processes, records, and closes complaint-handling activities in a timely manner.
• Conducts follow-up investigations with internal resources, field personnel and/or customer as
• Determines reportability of complaints per regulatory reporting requirements.
• Acts as an interface between EMEIA customer support team, Regulatory Post Market Surveillance team
• Evaluates and reports device malfunctions involving company products to the European regulatory

🎯 Requirements

• Knowledge / understanding of the European Medical Device Directive 93/43/EEC and MEDDEV 2.12-1.
• Understanding of quality records requirements and how they apply to complaint files and post market
• A Bachelor’s degree or Swiss CFC (Health sciences preferred).
• 6 months – 2 years of experience in complaint handling for medical devices.
• Ability to handle multiple tasks, to prioritize and schedule work to meet business needs.
• Demonstrate organizational and planning skills, including action oriented; focus urgency and