**Job Description Summary** As Regulatory Affairs Specialist you will support manufacturer activities including change control projects, NB interactions, audit support in RA role, international registration activity and manufacturing site support. **Job Description** **We are the makers of possible** 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. **Why join us?** A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place. Become a **maker of possible** with us! **Our vision for “Regulatory Affairs” at BD** The Regulatory Affairs team is helping to ensure speed to market for BD’s innovative medical technologies by having an acutely patient-centric mindset. **About the role** **As Regulatory Affairs Specialist you will** support manufacturer activities including change control projects, NB interactions, audit support in RA role, international registration activity and manufacturing site support. The Regulatory Affairs Specialist has to contact with local RA to get information about BU requirements related to international registration activities to get and maintain certification and commercialization authorizations of BD products. The function is to combine knowledge of scientific, regulatory and business issues to enable products to be sold WW. **Main responsibilities will include:** + CE mark certificate activities. + Technical documentation (creation, and maintenance). + International Registration activities (WW), including the preparation of regulatory dossiers to submit to Health Authorities, conduct legalization process and set registration strategies. + Change control projects, leading in RA role the projects to be implemented in manufacturing sites. + Standard assessment related to the determination of compliance about product design and production process. + Audit support: manufacturer and manufacturing sites. + Communication with Spanish CA on manufacturer responsibilities located in Spain. + NB communications: audits, change control submissions, vigilance process, certificates affairs. **About you** + 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 (MDR is required). + Experience with NB communications. + Experience working with International Standards and regulations including MDD, MDR, ISO 13485. + Proven knowledge and material experience in International registrations/ approval process for medical devices. + MDSAP knowledge is a plus. + Proficiency in English. + You should be an enthusiastic teammate, able to participate with dedication and sense of ownership in highly qualified teams, in a complex and fast evolving environment. **Click on apply if this sounds like you!** Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. **To learn more about BD visit:** **https://bd.com/careers** Required Skills Optional Skills . **Primary Work Location** ESP San Agustin del Guadalix **Additional Locations** **Work Shift** Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.