Boston Scientific Regulatory Affairs Specialist - CDMX 

Mexico, Quintana Roo 

123524273

, you will be responsible for managing the full cycle of sanitary registrations (New, Modifications, Renewals), advertising, and import permits for medical devices in Mexico. You will ensure timely approvals and maintenance of the necessary health authorizations for Boston products, maintaining effective communication with the health authorities and internal teams. You will participate in techno vigilance processes, renewal of registrations, import permits, administrative processes, and regulatory projects, directly contributing to the productivity, growth, and innovation of Boston Scientific in the Mexican market.

1. Bachelor's degree in areas related to the health sector (Pharmaceutical Chemist, Biomedical Engineering, Biological Sciences or related), license/degree.
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 (extensions) 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 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

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