Director - Regulatory Affairs & Quality Assurance - Olympus - Miami

Job description
The Director, RA/QA is a key role and will have a high level of visibility and interaction with Senior Leadership. This incumbent is responsible for leading the Regulatory Affairs & Quality Assurance function throughout Latin America. He/She will establish and maintain systems, processes and people management for multi-country compliance with regulatory and sanitary health laws and regulations (including Brazil, Mexico, Central and South America and the Caribbean.
The incumbent has the responsibility & accountability for the oversight and execution of product registrations, complaint and adverse event processing, inspections and audits, compliance, training, CAPAs, and other functional responsibilities throughout the Latin American region. EOE M/F/D/V

Job Requirements

Bachelors of Science Degree in Engineering or Scientific discipline is required.
Minimum of 10 years experience in regulatory affairs management is required.

Experience in the medical device industry strongly preferred.
Minimum of 7 years experience in Multi-Country international experience in Latin America is required.

Experience in Brazil, Mexico & Colombia strongly preferred.
Significant experience in interacting with regulatory authorities and government agencies is necessary.
Strong understanding of regulatory laws and requirements in Latin America with proven track record of success in speeding up RA process and time to market is essential.
Strong analytical and organizational skills required.
Strong written and verbal communication, presentation, and facilitation skills necessary.
Fluency in English, Spanish, or Portuguese a plus.

Strong leadership and people management skills, and the ability to quickly deal with low performance matters is essential.
Must be able to bring complexity into simple and actionable items when presenting to leadership.
Must be able to lead and manage a remote team and work side by side with marketing & MD in local markets.
Strong Project management skills in dashboard metrics presentation to track progress & development is necessary.

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