Regulatory Affairs Specialist (Comodoro Rivadavia)
Teladoc Health Ver todas las vacantes
- Comodoro Rivadavia, Chubut
- Permanente
- Tiempo completo
Essential Duties and ResponsibilitiesProvides high-quality support and assistance in areas related to regulatory strategy, product classification, and submissions to introduce new or changed medical devices and radio equipment to markets worldwide for Teladoc Health, Inc.
Assists with identifying applicable regulations, guidance documents, and standards for medical devices and radio equipment.
Prepares, reviews and files, as appropriate, FDA Annual Reports on Radiation Safety, EU technical documentation, Canada Medical Device Establishment Licenses, and no-file justifications.
Ensures consistency, completeness, and accuracy in regulatory documentation and adherence to regulations, applicable guidelines, and the Quality Management System.
Drives development and updates to regulatory affairs procedures, work instructions, and templates to improve operations or reflect changing regulatory requirements in collaboration with stakeholders and in line with the Quality Management System.
Conducts reviews of promotional and advertising material for compliance with standards and regulatory requirements. Assists with labeling development and reviews.
Conducts regulatory research and data collection to inform regulatory strategy and submissions. Understands, investigates, and evaluates regulatory history of products for context.
Supports FDA, notified body and other regulatory body inspections and audits, as needed.
Works in close collaboration with stakeholders and internal partners to achieve business objectives.
Maintains ongoing surveillance on the changing regulatory landscape, including domestic and international radio equipment and medical device regulations and guidance documents.
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