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About Rhian Convatec
Rhian Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs.
We are seeking an experienced Regulatory Affairs Specialist to join our team in Latin America. In this role, you will be responsible for managing and developing the successful coordination, compilation, submission, and approval of new medical devices with regulatory agencies.
Main Responsibilities
- Develop and implement regulatory strategies for new medical devices
- Compile and submit registration dossiers to regulatory authorities
- Collaborate with cross-functional teams to ensure compliance with regulatory requirements
- Provide direction on quality requirements for new and marketed products
- Support the implementation of long-term quality strategies and operating principles/practices
Requirements
- Bachelor's degree in a relevant health-related scientific discipline or an advanced degree in a related field
- Previous experience in medical device or pharmaceutical companies in Regulatory Affairs and Quality Assurance processes in Latin America
- Professional title and credentials as a technical and technovigilance responsible in Colombia or Peru
- Skill in authoring and compiling registration dossiers according to Andean Health Authorities rules
- Knowledge of regulatory entities and quality standards applicable in the region
- Demonstrated ability to partner with the business for the deployment of initiatives
