We are the people who give possibilities purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description
The Regulatory Affairs Specialist has to gain department and platform influence by co-operating in all RA accomplishments and sharing regulatory knowledge of demonstrating compliance with changing general regulations, also identifying, preparing and collecting data needed to acquire and maintain certifications and commercialization authorizations of BD products. The function is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured and distributed to meet applicable regulatory requirements and applicable technical standards.

Main responsibilities will include:





• Participation in cross-functional product development teams as the regulatory lead.
• Development of regulatory strategies for product release and product change assessments.
• Participate to the review of process/product changes, labeling, claims, product complaints, etc., to determine the need for any regulatory activities and to ensure compliance to Medical Devices regulations;
• Attends to audits performed by internal and external authorities to represent RA positions and processes;
• Creation, maintenance and updates of products Technical Files.
• OUS international product registrations attending to individual country specific requirements; monitor and report progress
• Assesses changes in regulations and helps to determine their impact.
• Prepare about regulatory documentation process for customs release process.
• Prepare regulatory dossiers for submission to Health Authorities

📌 Regulatory Affairs Specialist (San Agustín del Guadalix)
🏢 BD
📍 San Agustín del Guadalix