Market Surveillance Specialist (Temporary position)

Market Surveillance Specialist (Temporary position)

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Immunoassay business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Overview

The role involves managing customer complaints received via mail and SAP system, performing necessary testing, and providing timely responses. Responsibilities include preparing department metrics, reviewing notifications from official agencies, participating in the annual Post Market Surveillance Plan, and maintaining documentation and communication with customers and internal departments.

• Open complaints in SAP, assign complaint numbers, and notify customers.
• Gather missing information by following up with customers, and archive all communications and documents.
• Receive patient samples and kits for investigation.
• Coordinate consultations and verification procedures with relevant departments.
• Perform tests to investigate complaints and review customer-provided backups.
• Inform Quality Operations Director of investigation results and prepare final reports.
• Send reports to customers and document all activities in SAP.
• Archive documentation once complaints are closed.
• Review and circulate notifications from health agencies.
• Monitor department metrics and prepare Post Market Surveillance reports.
• Generate monthly complaints summaries.

Internal Networking

Qualifications

Minimum Knowledge & Experience

Degree in Science or Health-related field (Ciclo Formativo de Grado Superior), with laboratory experience in chemical, biological, or health-related areas.

Valuable : Additional higher degrees.

Experience

At least 2 years in a similar role.

Knowledge

Office tools (Excel & Word), basic SAP knowledge, fluency in Spanish or Catalan, and intermediate English skills.

Familiarity with Quality Management Systems.

Skills & Capabilities

Travel Requirements

Not required

What we offer

If you are eager to learn and face daily challenges, we encourage you to submit your resume or CV.

Werfen values diversity and is an Equal Opportunity Employer M / F / D / V.

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