Pl. Regulatory Analyst

This developing-level Regulatory Affairs position supports the Brazil Regulatory Affairs group to prepare
submission and registration documents supporting new or existing product offerings. The candidate must
work effectively with cross-functional groups and global regulatory affairs contacts to maintain Brazil
clearances/approvals.

Principal Responsibilities

• Understand regulatory processes, guidelines, and guidance documents and what they mean to the
organization.
• Communicate with internal stakeholders.
• Interface with various departments to collect and organize required documentation materials.
• Data entry, remediation, and maintenance of various regulatory databases.
• Assist in compiling new or revised medical device submissions and dossiers for import permits.
• Begin education on relevant domestic and Latin American regulatory requirements for medical
devices.
• Support the ...