Boston Scientific Regulatory Affairs Specialist II CDMX 

Mexico, Quintana Roo 

608065540

Purpose Statement

The Regulatory Affairs Specialist plays a vital role in enabling patient access to BSC technologies in Mexico by executing regulatory strategies to ensure timely product registrations and continued compliance with COFEPRIS and applicable regulations. This position supports new product launches, legacy product compliance, and regulatory lifecycle activities, contributing directly to BSC's success in one of the most critical markets in LATAM.

Required Qualifications

• Bachelor’s degree in Life Sciences (e.g., Pharmaceutical Sciences, Biomedical Engineering, Biotechnology).
• 5+ years of experience in Regulatory Affairs for medical devices or pharmaceuticals in Mexico.
• Solid knowledge of COFEPRIS regulations and submission pathways, including PND and modification procedures for Class III devices.
• Demonstrated experience preparing and submitting full Class III regulatory dossiers.
• Working knowledge of GMP certification, risk management (ISO 14971), clinical/performance evaluations, and local labeling/IFU compliance.
• Proficiency with Microsoft Office, Adobe Acrobat, and regulatory tools (e.g., Veeva Vault RIM, SAP PLM).
• English Proficiency: Intermediate to Advanced level (B2-C1 CEFR), capable of writing regulatory documentation, reading technical standards, and participating in calls or emails with regional and global counterparts.

Preferred Qualifications

• Experience with PND submissions and Class III implantable devices.
• Familiarity with Mexican NOMs (e.g., NOM-137, NOM-240, NOM-241, FEUM).
• Understanding of international regulatory frameworks (ISO 13485, DHRs, sterilization, stability).
• Prior involvement in post-market surveillance (e.g., Tecnovigilancia) and health authority interactions.

Nice-to-Have Skills:

• Experience using AI-enabled tools for document drafting, literature review, or regulatory intelligence (e.g., Microsoft Copilot, ChatGPT, or other LLM tools).
• Familiarity with global regulatory intelligence platforms and digital dashboards.
• Participation in cross-border RA projects or virtual team collaborations.