Quality & Post-Market Vigilance Specialist

Medtronic; Bogotá; Presencial; COP 60.000.000 - 90.000.000; Jornada completa

Descripción de la vacante

Medtronic is seeking a proactive professional for Post-Market Surveillance and Vigilance responsibilities in Bogotá. You will handle regulatory reporting, CAPA investigations, and complaint management while ensuring compliance with global standards and local regulations.

The role requires a Bachelor’s degree in a related field, fluent English, and 2–3 years of relevant experience in QA/RA or post-market activities. MS Office proficiency and knowledge of GDP/ISO 13485 are essential.

Formación

• Bachelor's Degree Required in Medical, Biological Science, Pharmaceutical Science, Engineering, or any related discipline.
• Fluent English level.
• Minimum of 2 to 3 years of experience in Post Market Surveillance, Vigilance or QA/RA role.
• MS Office Suite.
• At least 3 years of quality experience in the medical device industry or similar environment is an advantage.
• Good understanding of GDP and its implementation.
• Sound awareness and knowledge of ISO 13485 and its implementation.
• Complaint handling and Post Market Vigilance experience is an advantage.
• Strong experience and knowledge in regulatory requirements for adverse event reporting for approved devices is a great advantage.
• Experience in writing comprehensive regulatory reports is an advantage.

Responsabilidades

• Execute Complaint Handling activities, regulatory decisions and regulatory reporting.
• Use Global Complaint Handling system and related tools.
• Ensure timely closure of regulatory reports with investigation per regulatory requirements.
• Respond to stakeholder inquiries regarding status of regulatory decisions and reports.
• Assist in training personnel on system activities, complaint handling, regulatory reporting, and CAPA management.
• Monitor regulatory reporting deadlines and submit reports on time to authorities.
• Review and verify accuracy and completeness of regulatory reports before submission.
• Participate in CAPA investigations to identify root causes of quality issues and deviations.
• Document CAPA activities from stakeholders and global operations units.
• Audit processes for deviations or non-compliance and take corrective actions when needed.
• Participate in projects and process improvement initiatives; respond to stakeholder requests.
• Review complaint information and assess if reportable to regulatory bodies.
• Support tech/automation initiatives to improve Vigilance processes.
• Adapt to regulatory changes across regions.
• Support quality documentation updates and change initiatives.
• Prepare reports and analyze data to identify trends and improvement opportunities.
• Escalate high risk incidents to management and PMV team.
• Respond to audit enquiries and address recommendations.
• Observe health and safety policies and ensure actions do not compromise safety.

Conocimientos

Fluent English

Regulatory knowledge

Quality mindset

Attention to detail

Educación

Bachelor's Degree

Herramientas

MS Office

Regulatory systems

Descripción del empleo

Medtronic is seeking a proactive professional for Post-Market Surveillance and Vigilance responsibilities in Bogotá. You will handle regulatory reporting, CAPA investigations, and complaint management while ensuring compliance with global standards and local regulations.

The role requires a Bachelor’s degree in a related field, fluent English, and 2–3 years of relevant experience in QA/RA or post-market activities. MS Office proficiency and knowledge of GDP/ISO 13485 are essential.