Quality System & Regulatory Compliance Specialist

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

Descripción de la vacante

Medtronic is seeking a QA/RA professional to support Post Market Surveillance and regulatory reporting in Colombia. You will review complaints, ensure regulatory submissions are completed on time, and collaborate with cross-functional teams to maintain quality systems.

Responsibilities include CAPA investigations, data analysis, and preparation of regulatory reports while upholding GDP, ISO 13485 and global/regional requirements. Fluent English is required.

Formación

• Bachelor's degree in medical, biological, pharmaceutical, engineering or related field.
• Fluent English required.
• 2–3 years in post-market surveillance, vigilance or QA/RA.
• Proficient in MS Office.
• 3+ years quality experience in medical device industry.
• Good understanding of GDP and ISO 13485.

Responsabilidades

• Execute complaint handling and regulatory reporting tasks.
• Support CAPA investigations and root-cause analyses.
• Prepare regulatory reports and ensure timely submissions.
• Monitor regulatory reporting deadlines and compliance with requirements.
• Assist in training personnel on system activities and GMP processes.

Conocimientos

Fluent English

Regulatory reporting experience

Quality assurance experience

Educación

Bachelor's degree in Medical/ Biological/ Pharmaceutical/ Engineering or related discipline

Herramientas

MS Office Suite

Descripción del empleo

Medtronic is seeking a QA/RA professional to support Post Market Surveillance and regulatory reporting in Colombia. You will review complaints, ensure regulatory submissions are completed on time, and collaborate with cross-functional teams to maintain quality systems.

Responsibilities include CAPA investigations, data analysis, and preparation of regulatory reports while upholding GDP, ISO 13485 and global/regional requirements. Fluent English is required.