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 registrations in Chile.
- Coordinate regulatory activities with integral manufacturing sites to obtain and maintain the documentation required for regulatory submissions and product importation.
- Act as the primary liaison with the Chilean Health Authority (ISP) for assigned regulatory activities.
- Review regulatory documentation related to imported products and provide regulatory support to the Distribution Center.
- Partner closely with Quality, De

📌 Regulatory Affairs Support - Chile (Santiago)
🏢 Boston Scientific Gruppe
📍 Santiago