Regulatory Affairs Analyst Consultant (Medical Devices)

TL;DR

Regulatory Affairs Analyst Consultant (Medical Devices): Ensuring proper submission and approvals for market licenses, including new registrations, changes, and timely renewals, and establishment registrations. Focus on regulatory strategy, submission of changes, new registrations and renewals in a timely manner.

Location: Brazil

Company

hirify.global is a global full-service CRO with a strong focus on quality, professional development, and supportive culture.

What you will do

• Elaborate regulatory strategy and execute submission of changes, new registrations, and renewals in a timely manner.
• Execute activities to obtain or update establishment registration licenses.
• Execute post-approval activities such as preparation of communications to stakeholders, labels and Instructions for Use and system updates.
• Support regional team on product submissions schedules, prioritization, and pipeline management.
• Support internal and external audits with documentation requests.
• Review labels compliance in internal system.

Requirements

• Must have 1-2 years experience at least working in Regulatory Environment, preparing submissions for Brazilian Health Authorities and a successful track record.
• Desirable experience in Medical Devices or Pharma background.
• A Bachelor’s Degree in Engineering, Pharmacy or other life science.
• Advanced reading and writing Skills in English are required; intermediate to advanced speaking is desirable.
• Fluent in Portuguese.

Culture & Benefits

• Working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring.
• Global full-service CRO with a strong focus on quality, professional development, and supportive culture.