Regulatory Affairs Manager - Sao Paulo

Responsibilities

Responsible for managing and providing regulatory strategy for Brazil
Responsible for representing Integra Brazil during regulatory audits by ANVISA
Prepare and compile all Integra medical device registration submissions to ANVISA to obtain marketing authorization and maintain currently marketed products in compliance by submitting appropriate registration amendments and renewals when needed.
Represent Regulatory Affairs during MDSAP audits by Notified Body agencies
Prepare and/or review responses to ANVISA letters (e.g. Registration dossiers deficiencies, Requests for Additional Information)
Prepare and/or review Instructions for Use, Surgical Techniques, Product labels, and Promotional materials for Integra Brazil
Review product, design, and manufacturing changes and determine filing requirements
Ensures compliance with applicable Corporate and Divisional Policies and procedures
Provide regulatory input to product lifecycle planning
Perform other duties as required.

Qualifications

3-4 years of experience, and/or equivalent combination of education and experience, in preparing regulatory submissions for medical devices in Brazil
Experience working with regulatory authorities
Ability to prioritize projects, coordinate multiple projects simultaneously and work with tight deadlines

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