Regulatory Affairs Analyst — Global Medical Devices

Edwards Lifesciences Gruppe; Ciudad de México; Presencial; MXN 420.000 - 800.000; Jornada completa

Descripción de la vacante

Edwards Lifesciences in Mexico City seeks a Regulatory Affairs professional to navigate domestic and international approvals for our medical devices. You will support submissions, track timelines, and collaborate with cross-functional teams to protect proprietary information and ensure compliant product distribution.

With a bachelor’s degree and experience in regulatory affairs, you will develop strategy, prepare documentation for authorities, and help advance initiatives across country clusters

Formación

• Bachelor's degree in scientific discipline (e.g., Biology, Microbiology, Chemistry).
• Experience in preparing domestic and international product submissions preferred.
• Intermediate to advanced English level.

Responsabilidades

• Completes and maintains regulatory approvals and clearances of assigned products.
• Create regulatory submissions/playbook under close supervision, exercising judgment to protect proprietary information.
• Track timelines and document milestone achievements, participate in developing regulatory strategy.
• Develop routine Regulatory Affairs process improvement initiatives including system enhancements, training, reports and dashboards.
• Execute all RA activities in Edwards systems to ensure compliant product distribution.
• Prepare documents for submissions for appropriate regulatory bodies.

Conocimientos

Regulatory affairs

English proficiency

Problem solving

Team collaboration

Educación

Bachelor's degree in scientific discipline

Herramientas

Microsoft Office

Descripción del empleo

Edwards Lifesciences in Mexico City seeks a Regulatory Affairs professional to navigate domestic and international approvals for our medical devices. You will support submissions, track timelines, and collaborate with cross-functional teams to protect proprietary information and ensure compliant product distribution.

With a bachelor’s degree and experience in regulatory affairs, you will develop strategy, prepare documentation for authorities, and help advance initiatives across country clusters