Regulatory affairs specialist 2

876693

CRC Salario confidencial

Costa Rica Heredia

Publicado 3 Jun 2026

Aseguramiento de calidad

1 Vacante

Gestión de calidad

Asociación Solidarista de Empleados de Boston Scientific Costa Rica SRL
Industria de la empresa:
Industrias manufactureras

Descripción general

Specialist II, Regulatory Affairs – Neuromodulation

About the role:
The Regulatory Affairs Specialist II will support activities to drive alignment and consistency across the Neuromoduation RA Organization, throughout the product lifecycle. Working closely with functional leadership, this position will focus on continuous improvement of Neuromodulation RA data, processes, systems, and documents, and support projects to drive standardization and automation.
 
Your responsibilities include:
• Support RA systems, processes, and business process to improve the overall effectiveness of the Neuromodulation Regulatory Affairs function.
• Maintain regulatory systems to ensure data integrity, resolving data inconsistencies and producing various reports as needed.
• Support efforts to improve collaboration, experience sharing, and best practices within the department and division.
• Maintain regulated data for Neuromodulation using IT systems such as SharePoint, Microsoft Teams, Regis, Windchill, etc.
• Support regulatory information requests in support of audits, customs, post-market surveillance, government authorities, etc.
• Provide focused regional support and triage/monitor global registration requests
• Assist in the creation, maintenance, and tracking of submissions (i.e. 510(k), CE marking applications/change notices, technical documentation, requests for additional information, etc.)
• Act as a core team member on global project teams, providing Regulatory Affairs feedback and guidance
• Assist in monitoring and analyzing the impact of emerging or revised laws, regulations, enforcement actions and other changes that impact the manner by which products are regulated around the world
• Support and maintain Quality initiatives in accordance with BSC Quality Policy
• Other duties as assigned

What we’re looking for:
Basic Qualifications:
• Bachelor’s degree, preferably in a scientific or technical discipline.
• A minimum 2 years Regulatory Affairs or related experience, medical device industry experience preferred.
• Working knowledge of FDA and EU regulations for medical devices (Class III, Class II).
• General understanding of product development process and design control.

Preferred qualifications:
• Ability to manage several projects
• High attention to detail, task oriented, deadline conscientious
• Proficiency in Excel with ability to convert data for more effective analysis
• Advanced knowledge of Microsoft applications, including creating templates and editing/formatting complex documents in Word, PowerPoint, Visio, & Excel
• Effective research, analytical, and problem-solving skills
• Effective written and oral communication, technical writing, and editing skills
• Ability to work independently within defined parameters
• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures
• Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy
• Establishes and promotes a work environment that supports the Quality Policy and Quality System

Competencias para la vacante

Datos complementarios

876693

Profesional

Bachillerato universitario

Equipo medico

2 años de experiencia

Contrato Temporal

876693

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