Regulatory Complaints & Submissions Specialist

Zimmer Biomet; Bogotá; Presencial; COP 24.000.000 - 42.000.000; Jornada completa

Descripción de la vacante

Zimmer Biomet in Bogotá seeks a Complaint Management Specialist to gather and evaluate complaint data, assess regulatory reporting needs, and submit reports to FDA or regional authorities. The role requires strong organization and communication skills, attention to detail, and collaboration across teams.

Responsibilities include maintaining records, supporting department metrics, and assisting with special projects. English proficiency and a background in medical devices are preferred.

Formación

• Bachelor of Science degree in biology, health sciences, engineering, or nursing preferred.
• English language proficiency for communication.
• Co-op or intern experience in medical devices preferred.

Responsabilidades

• Adheres to all corporate and site specific procedures.
• Documents and maintains records in accordance with procedures.
• Gathers pertinent details of the complaint event.
• Assesses complaint events for regulatory reporting requirements.
• Submits regulatory reports to FDA or Regional Competent Authority within regulatory timeframes.
• Supports the completion of complaint activities in line with department metrics and KPIs.
• Assists Management in special projects as required.

Conocimientos

Organizational skills

Time management

Communication skills

Written communication

Oral communication

Presentation skills

Educación

BS degree in biology/health sciences/engineering/nursing

BA/BS in another discipline with relevant experience

Herramientas

EtQ

JD Edwards

Internet

Microsoft Office

Descripción del empleo

Zimmer Biomet in Bogotá seeks a Complaint Management Specialist to gather and evaluate complaint data, assess regulatory reporting needs, and submit reports to FDA or regional authorities. The role requires strong organization and communication skills, attention to detail, and collaboration across teams.

Responsibilities include maintaining records, supporting department metrics, and assisting with special projects. English proficiency and a background in medical devices are preferred.