Company: B. BRAUN MEDICAL BBMX

Ubicación: CDMX

Modelo de trabajo: Híbrido

At B. Braun, we believe that every innovation begins with a deep commitment to care.

As one of the world’s most respected leaders in medical device solutions, we bring together knowledge, passion, and expertise to enhance the quality of life for patients across the globe. Since our founding in Melsungen, Germany in 1839, we’ve grown through a profound understanding of our customers’ needs and a relentless pursuit of excellence.

Improving health is a journey filled with challenges and opportunities.

What drives our success? The power of collaboration. We co-create innovative solutions with our customers and partners through open, constructive dialogue. Together, we shape the future of healthcare.

If you’re someone who thrives on new challenges, embraces continuous learning, and seeks professional growth in a multicultural, global environment, we invite you to be part of this mission. Explore the opportunity below and take the next step in your career with B. Braun.

Why is this a good opportunity for me?

Lead the Regulatory Affairs strategy and operations to ensure that products have the regulatory authorizations and conditions required for importation, commercialization, and post-market surveillance in Mexico. Direct the team, anticipate risks, and coordinate with internal departments, manufacturers, and authorities to maintain compliance and business continuity

Key Responsibilities

- Lead regulatory strategy and lifecycle management for the product portfolio, including registrations, renewals, variations, and dossier maintenance.
- Ensure regulatory compliance across import/export activities, labeling,



promotional materials, and product documentation.
- Manage regulatory agency interactions, coordinating submissions, inspections, commitments, and responses to health authority requests.
- Oversee vigilance activities for medical devices and pharmaceutical products, ensuring compliance with applicable reporting requirements & monitor regulatory performance and portfolio health, ensuring effective controls, compliance, and timely decision-making.
- Assess regulatory changes and business impact, mitigating risks and supporting supply continuity.
- Provide strategic regulatory guidance to cross-functional teams on product launches, changes, and business initiatives.
- Drive stakeholder engagement with manufacturers, registration holders, authorities, and global partners.

Education & Experiencie

Bachelor's degree in a Health Sciences-related field (Pharmacy, Pharmaceutical Chemistry, Biomedical Engineering, Biotechnology, or equivalent) with 8+ years of Regulatory Affairs experience, leading regulatory strategy, product registrations, and health authority interactions, particularly with COFEPRIS. Proven track record of leading teams, driving operational excellence, and delivering business results.

Languages & Tools

Advanced English proficiency for effective collaboration with integral stakeholders. Strong knowledge of Microsoft Office, COFEPRIS platforms, and regulatory management systems.

What we offer

Be part of a company culture that actively promotes constructive exchanges between colleagues, customers and partners. Work with us to improve people's lives in the long term. We can offer you interesting and varied tasks and excellent opportunities to work with us.

📌 Regulatory Affairs Manager (Ciudad de México)
🏢 B. Braun Group
📍 Ciudad de México