Description |
Miami, FL - The Manager, Regulatory Affairs/Quality Assurance will be responsible for establishing and maintaining compliance with regulatory and sanitary health laws and regulations throughout Latin America (excepting Brazil), including the management of product registrations, complaint and adverse event processing, inspections and audits, compliance, training, CAPAs, and other department responsibilities. EOE M/F/D/V
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Requirements |
* Manage, mentor, and supervise all RA/QA staff in the Olympus Latin America (OLA) office to ensure the effective performance of RA/QA responsibilities.
* Establish, implement, monitor, and maintain product registrations and renewals for all of Latin America, except Brazil.
* Work with OLA and Olympus Corporation of the Americas (OCA) Management to plan and schedule product registration and renewal activities and successfully execute against these plans and schedules.
* Provide regular reports on product registration and renewal status to OLA and OCA Management and Olympus M-BCs.
* Establish, implement, monitor, and maintain a vigilance process for Latin America.
* Ensure that adverse events and other product quality issues are investigated, documented, and reported in a timely manner to local authorities and, whenever appropriate, to OCA RA/QA.
* Support ship holds, recalls, corrections, and removals whenever needed in the Latin American market.
* Interact with distributors, consultants, sanitary health authorities, and regulatory bodies throughout the Latin American region on compliance related matters.
* Travel to meet with representatives from distributors, consultants, health authorities, and regulatory bodies in their home countries when necessary.
* Ensure OLA's compliance with internal and external regulatory and quality system requirements.
* Maintain awareness of changing regulations and requirements in all Latin American countries.
* Report on any changes to Olympus Management, including representatives from Olympus manufacturers.
* Provide ongoing analysis on the likely impact of changes to the regulatory environment in Latin America.
* Supervise Specialist, Regulatory Affairs/Quality Assurance (OLA) and Document Control Coordinator (OLA).
* Perform other related duties as assigned.
Qualifications:
(ONLY QUALIFIED CANDIDATES WILL BE CONSIDERED)
* A Bachelor of Science Degree in Engineering or Scientific discipline is preferred.
* A minimum of 5 years of experience in a drug/device manufacturer/distributor environment in the Latin American market is required, with strong concentration in product registrations, adverse event reporting, and vigilance.
* Strong analytical and organizational skills are essential.
* Must have strong communication skills in both English and Spanish.
* The following physical demand is required:
-Stand/Sit/Walk 8 hours a day
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