Global Senior Regulatory Affairs Leader – Medical Devices

Teleflex; Ciudad de México; Presencial; MXN 920,000 - 1,290,000; Jornada completa

Descripción de la vacante

A global medical technology provider seeks a Senior Regulatory Affairs Specialist in Mexico City. This role focuses on regulatory activities, ensuring compliance for medical devices in line with US, EU, and Canada regulations. Candidates require a Bachelor's in Science or Engineering and 5+ years in the industry, specifically with Class II devices. Strong technical writing and problem-solving skills are essential, along with fluent English proficiency.

Formación

• 5+ years of experience in the medical device industry.
• Experience with Class II or higher registrations.
• Fluent in English, both written and oral.
• Strong understanding of US, EU, and Canada medical device regulations.

Responsabilidades

• Develop and execute regulatory strategies for new products.
• Conduct regulatory research and assessments.
• Collaborate with cross-functional teams to manage regulatory activities.
• Interact with regulatory authorities for product lifecycle management.

Conocimientos

Technical writing

Regulatory compliance

Problem solving

Attention to detail

Communication skills

Educación

Bachelor Degree in Science or Engineering

Herramientas

MS Office

Descripción del empleo

A global medical technology provider seeks a Senior Regulatory Affairs Specialist in Mexico City. This role focuses on regulatory activities, ensuring compliance for medical devices in line with US, EU, and Canada regulations. Candidates require a Bachelor's in Science or Engineering and 5+ years in the industry, specifically with Class II devices. Strong technical writing and problem-solving skills are essential, along with fluent English proficiency.