Regulatory Affairs Support - Chile

Diversidad - Innovación - Preocupación - Colaboración global - Espíritu ganador - Preocupación - Alto rendimiento

En Boston Scientific, le brindaremos la oportunidad 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 registrations in Chile.
• Coordinate regulatory activities with global 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, Demand Planning, Business Unit Managers (BUMs), Supply Chain, and other cross-functional teams to ensure regulatory compliance throughout the product lifecycle.
• Monitor changes in local regulations and assess their impact on the business, providing timely recommendations to internal stakeholders.
• Maintain regulatory databases, documentation, and internal systems, ensuring data integrity and compliance.
• Support continuous improvement initiatives by leveraging digital tools and AI-enabled solutions to optimize regulatory processes.
• Develop and maintain strong collaborative relationships with both internal and external stakeholders.
• Support the company's participation in industry associations.

Required qualifications (Must Have)

• Bachelor's Degree in Pharmacy, Biochemistry, Medical Technology, Biomedical Engineering, or another related scientific discipline.
• Previous experience in Regulatory Affairs within the healthcare, pharmaceutical, or medical device industry.
• Advanced English proficiency (written and spoken).
• Experience interacting with health authorities (preferably ISP or equivalent regulatory agencies).
• Strong analytical skills with exceptional attention to detail.
• Excellent written and verbal communication skills.
• Ability to interpret regulatory requirements and scientific documentation.
• Experience working with multiple systems, databases, and digital platforms.
• Proven ability to collaborate effectively with cross-functional teams.
• Strong organizational skills and ability to manage multiple priorities simultaneously.

Preferred qualifications (Nice to Have)

• Previous experience in Medical Devices Regulatory Affairs.
• Experience supporting product importation and Distribution Center operations.
• Knowledge of Chilean medical device regulations and the upcoming regulatory framework.
• Experience working with global manufacturing sites and international stakeholders.
• Experience participating in regulatory inspections or health authority interactions.
• Digital mindset with experience leveraging automation, AI tools, or digital solutions to improve processes.
• Experience representing a company before industry associations or external regulatory forums.
• Project management experience in cross-functional environments.

Númerode la requisición: 632422

Como líder en ciencia médica durante más de 40 años, estamos comprometidos a resolver los desafíos que más importan, unidos por un profundo cuidado por la vida humana. Nuestra misión de promover la ciencia de por vida consiste en transformar vidas a través de soluciones médicas innovadoras que mejoran la vida de los pacientes, crean valor para nuestros clientes y apoyan a nuestros empleados y las comunidades en las que operamos. Ahora más que nunca, tenemos la responsabilidad de aplicar esos valores a todo lo que hacemos, como empresa global y como ciudadano corporativo global.