Compliance

• 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.
• Under supervision, provide administrative support to the Brazil Regulatory Affairs group, with activities that include securing certified copies, processing payment requests, and coordinating dossier deliveries to third parties.
• Assist in the regulatory due diligence process.

Regulatory Affairs Associate

Senior Scientist, Regulatory Affairs – Chemistry Manufacturing & Controls