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  • Regulatory Affairs Specialist I - Ciudad de México - Boston Scientific

    Boston Scientific
    Boston Scientific Ciudad de México

    hace 1 mes

    Default job background
    Ingeniería / Arquitectura
    Descripción

    About Boston Scientific:

    We are a leader in medical science for over 40 years, committed to solving the challenges that matter most. Our mission is to advance science for life, transforming lives through innovative medical solutions that improve patient outcomes and create value for our customers.

    Job Summary:

    The Regulatory Affairs Specialist I will manage the full cycle of sanitary registrations, advertising, and import permits for medical devices in Mexico. This role requires effective communication with health authorities and internal teams to ensure timely approvals and maintenance of necessary health authorizations for Boston products.

    Main Responsibilities:

    1. Manage new, modification, and renewal sanitary registrations, as well as import permits for medical devices in Mexico
    2. Maintain effective communication with health authorities and internal teams to ensure timely approvals
    3. Participate in techno vigilance processes and regulatory projects to contribute to productivity, growth, and innovation of Boston Scientific in the Mexican market
    4. Ensure compliance with COFEPRIS rules and regulations applicable to medical devices

    Requirements:

    1. Bachelor's degree in areas related to the health sector (Pharmaceutical Chemist, Biomedical Engineering, Biological Sciences or related)
    2. 1-3 years of experience in regulatory affairs for medical devices
    3. Solid knowledge of COFEPRIS rules and regulations applicable to medical devices
    4. Proven experience in managing sanitary registrations, renewals, and import permits
    5. Ability to interpret regulatory requirements and apply them to specific situations
    6. Experience in filing procedures with COFEPRIS and using government platforms
    7. Excellent project organization, prioritization, and tracking skills
    8. Ability to work on multiple projects simultaneously meeting deadlines
    9. Deep knowledge of Microsoft Office (Excel, PowerPoint, Word)
    10. English level B2 or higher (reading, writing, and speaking)
    11. Accountability, attention to detail, and a sense of urgency
    12. Availability for hybrid work with 3-day on-site attendance at the office

    Preferred Qualifications:

    1. Previous experience in multinational companies in the healthcare/medical device sector
    2. Knowledge of the Latin American regulatory environment
    3. Experience in regulatory management systems (RIMs) and specialized databases
    4. Familiarity with ISO 13485, NOM-240, and international standards applicable to medical devices
    5. Participation in industry associations/groups in the sector
    6. Experience in communicating with multiple stakeholders and different organizational levels
    7. Knowledge in techno vigilance and adverse event management
    8. Strategic thinking skills and business vision
    9. Experience in project management tools

    This role offers ongoing professional development and the opportunity to positively impact patients' lives through innovative medical technologies. We encourage you to apply if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference worldwide.


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