Title:  Senior Regulatory Issues Coordinatorr

Organize the documentation required for sanitary registration procedures, in accordance with INVIMA requirements regarding the submission of virtual information.

Submit requests to INVIMA for the issuance of sanitary registrations for new medical devices and reagents.

Process renewals of sanitary registrations requested by the marketing and sales departments.

Manage periodic visits to INVIMA for inquiries, new policies, format updates, and other related activities.

Maintain organized databases and matrices containing information on the sanitary registrations obtained by the company.

Keep physical and digital records of the resolutions for each sanitary registration well organized.

Respond to official notices and requests issued by INVIMA related to the company’s sanitary registrations.

Keep the different involved departments informed about upcoming sanitary registration expirations in order to evaluate renewals or label depletion.

Conduct timely follow-up on third-party procedures, such as translations of information required for sanitary registration applications.

Maintain constant communication with the involved departments to add or remove distributors and keep their information updated in each sanitary registration.

Thoroughly verify that the information in approved sanitary registrations matches the requirements of the different departments to avoid additional costs due to later modifications.

Take responsibility for regulatory procedures related to the product lines (PMLS, IVD, MIS, orthopedics).

Prepare and monitor the regulatory tracking table to ensure compliance with the work plan.

Process the various regulatory department payment applications on the Concur platform.