Regulatory Affairs Support - 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

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.