Regulatory Affairs Specialist II| CDMX

Boston Scientific Gruppe; México; Presencial; USD 25,000 - 45,000; Jornada completa

Descripción de la vacante

Boston Scientific seeks a Regulatory Affairs Specialist in Mexico to support product registrations and compliance with COFEPRIS regulations. The role requires a Bachelor's degree in Life Sciences and 5+ years of experience in regulatory functions, particularly for medical devices. Ideal candidates will have solid knowledge of regulatory pathways and strong documentation skills. This is an excellent opportunity to contribute to patient access and impactful health solutions.

Formación

• 5+ years of experience in Regulatory Affairs for medical devices or pharmaceuticals.
• Solid knowledge of COFEPRIS regulations and submission pathways.
• Demonstrated experience preparing and submitting full Class III regulatory dossiers.

Responsabilidades

• Execute regulatory strategies for timely product registrations.
• Support new product launches and legacy product compliance.
• Contribute to regulatory lifecycle activities.

Conocimientos

Knowledge of COFEPRIS regulations

Regulatory documentation

Risk management (ISO 14971)

English Proficiency

Educación

Bachelor’s degree in Life Sciences

Herramientas

Microsoft Office

Adobe Acrobat

Regulatory tools (e.g., Veeva Vault RIM, SAP PLM)

Descripción del empleo

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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.

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.

Requisition ID:608169

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!

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