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Organize the documentation required for sanitary registration procedures, in accordance with INVIMA requirements regarding the submission of virtual information.
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Submit requests to INVIMA for the issuance of sanitary registrations for new medical devices and reagents.
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Process renewals of sanitary registrations requested by the marketing and sales departments.
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Manage periodic visits to INVIMA for inquiries, new policies, format updates, and other related activities.
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Maintain organized databases and matrices containing information on the sanitary registrations obtained by the company.
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Keep physical and digital records of the resolutions for each sanitary registration well organized.
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Respond to official notices and requests issued by INVIMA related to the company’s sanitary registrations.
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Keep the different involved departments informed about upcoming sanitary registration expirations in order to evaluate renewals or label depletion.
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Conduct timely follow-up on third-party procedures, such as translations of information required for sanitary registration applications.
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Maintain constant communication with the involved departments to add or remove distributors and keep their information updated in each sanitary registration.
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Thoroughly verify that the information in approved sanitary registrations matches the requirements of the different departments to avoid additional costs due to later modifications.
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Take responsibility for regulatory procedures related to the product lines (PMLS, IVD, MIS, orthopedics).
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Prepare and monitor the regulatory tracking table to ensure compliance with the work plan.
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Process the various regulatory department payment applications on the Concur platform.
Postúlate en Kit Empleo: kitempleo.com.co/empleo/1ar6dp