Job Description:
Responsible for overseeing the planning of registration projects, including budgeting, submissions to the Ministry of Health, and obtaining approval for new licenses, renewals, modifications, import permits, advertising notices, technovigilance reports, and NOM 137 product labeling. This position must be updated on every regulatory change applicable to medical devices.
Job Requirements:
Registration Project Planning - MX Planning new product registrations based on project management requests. Planning license renewals, modifications, import permits, and technovigilance reports. Managing appointments with COFEPRIS (Federal Commission for Protection against Sanitary Risks). Updating and submitting the monthly RA registration tracker (LATAM RA-Projects). Registrations with the Ministry of Health - MX Requesting information/documents from the manufacturer and following up. Preparing dossiers for new registrations, renewals, modifications, import permits, technovigilance reports, advertising notices, and NOM 137 product labeling. Submitting final dossiers to the Ministry of Health. Following up on and monitoring approvals or clarifications from the Ministry of Health. In case of clarifications, respond to the authorities to continue the registration process. Collect physical approvals from the Ministry of Health. Notify the sales, marketing, and warehouse/supply chain teams of approvals so they can begin the launch process. Support registration projects - LATAM Plan registrations for new products, license renewals, and modifications based on distributor requests. Prepare documentation for new registrations, renewals, and modifications. Review with manufacturers the documents, information, and Spanish translations required by distributors. Submit documents to the Ministry of Health through local distributors.
Operating Company:
OrmcoOrmco is a global leader and innovator of high-quality orthodontic products and solutions, including brackets and wires. For more than 60 years, our team has partnered with the orthodontic community to help create over 20 million smiles in more than 140 countries. We build trusted relationships. Each one is rooted in respect and understanding. We take that approach when we help orthodontists achieve their clinical and practice management objectives. We take the same approach when we help our team bring their personal best to work each day, ready to make a difference and reach their full potential.
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