Regulatory Affairs Specialist - Medical Devices (Chile)

Boston Scientific Gruppe; Santiago; Presencial; CLP 26.784.000 - 40.176.000; Jornada completa

Descripción de la vacante

Boston Scientific Chile is seeking a Regulatory Affairs Specialist to help implement new regulatory requirements for medical devices and to prepare the transition to mandatory ISP registrations starting in March 2028. You will collaborate with global manufacturing sites, QA, Demand Planning, BUMs, and the Distribution Center to ensure regulatory compliance and business continuity.

The role involves maintaining regulatory documents, supporting submissions, monitoring changes in Chilean

Formación

• Advanced English proficiency (written and spoken).
• Strong analytical skills with attention to detail.
• Ability to interpret regulatory requirements and scientific documentation.
• Excellent written and verbal communication skills.
• Proven ability to collaborate with cross-functional teams.
• Experience working with multiple systems, databases, and digital platforms.

Responsabilidades

• Support preparation, submission, maintenance, and lifecycle management of regulatory registrations in Chile.
• Coordinate regulatory activities with global manufacturing sites for documentation and importation.
• Act as liaison with ISP for assigned regulatory activities.
• Review regulatory documentation for imported products and provide regulatory support to the Distribution Center.
• Collaborate with QA, Demand Planning, BUMs, Supply Chain, and others to ensure compliance throughout the lifecycle.
• Monitor regulatory changes and advise stakeholders on potential impact and actions.

Conocimientos

Advanced English

Analytical skills

Regulatory interpretation

Communication skills

Cross-functional collaboration

Data management

Educación

Bachelor's Degree in Pharmacy or related

Descripción del empleo

Boston Scientific Chile is seeking a Regulatory Affairs Specialist to help implement new regulatory requirements for medical devices and to prepare the transition to mandatory ISP registrations starting in March 2028. You will collaborate with global manufacturing sites, QA, Demand Planning, BUMs, and the Distribution Center to ensure regulatory compliance and business continuity.

The role involves maintaining regulatory documents, supporting submissions, monitoring changes in Chilean