Post Market Surveillance Specialist AE (Medical Devices)

Location: Hybrid (50-60% WFH in Sânandrei, Timis, Romania)

Company

hirify.global is a global medical and pharmaceutical device company dedicated to protecting and improving the health of people worldwide.

What you will do

• Verify complaints in the database and register cases for regions without SAP/C3 connection.
• Collect critical information from representatives and distributors regarding product complaints.
• Create detailed customer complaint reports and perform data analyses.
• Maintain failure mode catalogues using IMDRF coding for accurate complaint classification.
• Manage SAP requests for credit notes, repairs, cost estimates, and product returns.
• Coordinate international cooperation within the division's PMS process, including occasional travel to Germany.

Requirements

• Higher education in Medical Engineering, Quality Management, or related fields.
• 1-2 years of professional experience, ideally in quality assurance or customer service.
• Proficiency in SAP and MS Office tools (Word, Excel, PowerPoint, Outlook).
• Knowledge of medical device regulations and standards (EN ISO 13485, EU Regulation, 21 CFR).
• English: Advanced proficiency (C1) written and spoken.
• Location: Must be based in or able to work from the Sânandrei, Timis office.

Culture & Benefits

• Unlimited period employment contract.
• Annual performance-based bonus.
• Hybrid working model with 50-60% work-from-home flexibility.
• Meal tickets and health subscription for discounted medical services.
• 7 Card subscription and premiums for family events.
• Partial reimbursement for the purchase of eyeglasses.