Regulatory Affairs Specialist I - CDMX

Additional Locations: N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

About the role:

As a Regulatory Affairs Specialist I, 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.

Required qualifications:

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

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

The selected person will join a dynamic team that values innovation, collaboration and excellence, working in a patient-centered and results-oriented environment. At Boston Scientific, we offer ongoing professional development and the opportunity to positively impact patients' lives through innovative medical technologies.

Requisition ID:603751

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!