We are the people who give possibilities purpose BD is one of the largest integral medical technology companies in the world. 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. 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 global 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. to determine the need for any regulatory activities and to ensure compliance to Medical Devices regulations; 2
- 3 years experience in regulatory affairs within the medical devices technology industry. ~ Compliance experience with Class I/IIa/III products under MDR. ~ Have knowledge of the regulatory framework pertaining to Medical Devices such MDR CE Marking.



~ Experience working with International Standards in particular ISO 7864, ISO 7886, ISO 6009, ISO 9626, 62366(usability), ISO 14971 and ISO 13485; Good working knowledge of Design Control, Risk Mgmt, V&V; processes. ~ Proven knowledge and material experience in International registrations/ approval process for medical devices. ~ Fluent in English as you will be working in an international environment. ~ You should be an enthusiastic teammate, able to participate with commitment and sense of ownership in highly qualified teams, in a complex and fast evolving environment. Additional Locations Work Shift We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. Our salary or hourly rate ranges reward associates fairly and competitively. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

📌 Regulatory Specialist and Senior Specialist (Lozoya)
🏢 BD
📍 Lozoya