Regulatory Affairs Specialist - Medical Devices

at  Roche

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The Position
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.

• Regulatory Strategy & Compliance:
• Develop and implement regulatory strategies for Argentina, Uruguay, Bolivia, and Paraguay.
• Ensure that all products meet the necessary regulatory requirements for these markets, with a primary focus on Argentina.
• Stay updated on regulatory changes in the four countries and assess their impact on company operations.
• Manage the import permit process at ANMAT (14 puntos; Disposición ANMAT 2675/99).
• Regulatory Submissions:
• Prepare, compile, and submit regulatory documents to relevant authorities in Argentina, Uruguay, Bolivia, and Paraguay for product approvals, renewals, and variations.
• Manage interactions and communications with regulatory agencies during the submission and approval process.
• Relationship Management with Health Authorities:
• Establish and maintain strong relationships with health authorities in Argentina, and trade associations and support the interaction with other agencies of the network.
• Act as the primary liaison between the company and health authorities to facilitate smooth communication and collaboration (Argentina for dossiers evaluations).
• Attend meetings, workshops, and conferences hosted by health authorities to stay informed on regulatory trends and updates.
• Ensure that health authorities are kept informed of the company’s regulatory activities, product launches, and compliance status.
• Cross-functional Collaboration:
• Provide regulatory guidance to customer support, logistic, quality, and marketing teams to ensure compliance throughout the product development lifecycle, particularly in Argentina.
• Participate in cross-functional meetings to advise on regulatory requirements and timelines for all four countries.
• Support the development of product labeling, advertising, and promotional materials in line with regulatory guidelines.
• Post-market Surveillance & Compliance:
• Monitor and manage post-market surveillance activities, including adverse event reporting and product recalls.
• Ensure ongoing compliance with regulatory requirements, including the maintenance of product registrations and licenses in all four countries.
• Conduct audits and inspections to assess compliance with regulatory standards.
• Documentation & Record Keeping:
• Maintain accurate and complete regulatory files and records for Argentina, Uruguay, Bolivia, and Paraguay.
• Ensure that all documentation is compliant with regulatory requirements and is readily accessible for audits and inspections.
• Prepare and review regulatory reports and correspondence