EU Post Market Surveillance Specialist

About the role

Intuitive, a pioneer in robotic-assisted surgery, is looking for a Post Market Surveillance Specialist in Madrid. The specialist supports the Regulatory Department by reviewing and evaluating product complaints, deciding whether they require vigilance reporting and gathering supporting data.

Key responsibilities

• Evaluate incoming complaint information and maintain records in the electronic database according to company procedures.
• Work with Customer Service on product returns linked to complaints, and process, record and close complaint activities promptly.
• Carry out follow-up investigations with internal resources, field personnel and customers to collect data for trending.
• Determine the reportability of complaints under regulatory requirements.
• Act as interface between the EMEA customer support team and the Regulatory Post Market Surveillance team for US and European customers, including distributors.
• Evaluate and report device malfunctions to European regulatory agencies, and collect, trend and escalate PMS data.
• Support colleagues and field personnel, and take on other regulatory tasks and projects as needed.

Required profile

• Bachelor's degree or Swiss CFC (Health Sciences preferred).
• 6 months to 2 years of experience in complaint handling for medical devices.
• Fluent written and spoken English, Spanish and Portuguese.
• Ability to handle multiple tasks, prioritize and communicate well, both in person and by phone and in writing.

Required skills

• Knowledge of EU MDR, MDCG guidance, UK Medical Devices Regulations 2002 (MHRA vigilance) and Swiss MedDO (Swissmedic vigilance).
• Understanding of quality records requirements for complaint files and PMS reports.
• General computer literacy (Word, Excel, PowerPoint, Outlook); TrackWise, ERP/CRM (e.g. SAP) or Salesforce is a plus.
• Basic knowledge of US FDA 21 CFR Parts 803, 806 and 820 is a plus.