Post Market Surveillance Specialist supporting the Regulatory Department in Madrid. The role involves reviewing product complaints, evaluating regulatory reportability, conducting investigations, and maintaining compliance records for medical devices across European markets.
Responsibilities
- Evaluate incoming complaints and maintain records in electronic database per company procedures
- Conduct follow-up investigations with internal teams, field personnel, and customers to gather event information
- Determine regulatory reportability of complaints per EU requirements and escalate data trends
- Interface between EMEIA customer support, US Regulatory Post Market Surveillance team, and European customers




- Report device malfunctions to European regulatory agencies and support complaint closure activities

Requirements
- Knowledge of European Medical Device Directive 93/43/EEC and MEDDEV 2.12-1
- Bachelor's degree or Swiss CFC in health sciences preferred
- 6 months to 2 years complaint handling experience in medical devices
- Fluent in written and spoken English, Spanish, and Portuguese
- Strong organizational skills with ability to prioritize multiple tasks
- Excellent written, verbal, and interpersonal communication abilities
- General PC proficiency including Microsoft Office and Outlook

📌 EU Post Market Surveillance Specialist (España)
🏢 Intuitive Surgical
📍 España