Pl. Regulatory Analyst

Há 2 dias


São Paulo, Brasil Teleflex Tempo inteiro

Position Summary This developing-level Regulatory Affairs position supports the Brazil Regulatory Affairs group to preparesubmission and registration documents supporting new or existing product offerings. The candidate mustwork effectively with cross-functional groups and global regulatory affairs contacts to maintain Brazilclearances/approvals. Principal Responsibilities • Understand regulatory processes, guidelines, and guidance documents and what they mean to theorganization.• 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 medicaldevices.• Support the Regulatory Impact Assessment process.• Discuss about GAP Assessments regarding regulatory updates.• Provide administrative support to the Brazil Regulatory Affairs group, including securing certifiedcopies, processing


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