10 ago
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Boston Scientific
|
Chile
10 ago
Boston Scientific
Chile
Diversidad - Innovación - Preocupación - Colaboración global - Espíritu ganador - Preocupación - Alto rendimiento
En Boston Scientific, le brindaremos la posibilidad de aprovechar todo lo que hay dentro de usted trabajando en equipos de empleados diversos y de alto rendimiento, abordando algunos de los desafíos más importantes de la industria de la salud. Con acceso a las últimas herramientas, información y capacitación, lo ayudaremos a mejorar sus habilidades y su carrera. Aquí, recibirá apoyo para progresar, sean cuales sean sus ambiciones.
About the role:
This position will play a key role in supporting Boston Scientific Chile in the implementation of the new regulatory requirements for medical devices, ensuring compliance with the upcoming mandatory registration process before the Chilean Health Authority (ISP).
The Regulatory Affairs Specialist will work closely with global manufacturing sites, the Chilean Health Authority (ISP), Quality (QA), Demand Planning, Business Unit Managers (BUMs),
and the Distribution Center to ensure regulatory compliance and business continuity.
In addition, this role will help strengthen relationships with external regulatory authorities and support the company's representation in industry associations.
This position will play a key role in preparing Boston Scientific Chile for the implementation of new regulatory requirements for medical devices, supporting the transition to mandatory ISP registrations starting in March 2028. The Regulatory Affairs Specialist will collaborate closely with global manufacturing sites, the Chilean Health Authority (ISP), Quality Assurance, Demand Planning, Business Unit Managers, and the Distribution Center to ensure regulatory compliance and business continuity. This role will also contribute to strengthening external regulatory engagement and industry representation.
Responsibilities:
- Support the preparation, submission, maintenance, and lifecycle management of medical device regulatory re
📌 Regulatory Affairs Support (Chile)
🏢 Boston Scientific
📍 Chile