Regulatory Affairs Specialist

hace 4 días


San Agustín del Guadalix, España BD A tiempo completo

Overview Job Description Summary Being a key strategic partner for the EMEA BD Business by (i) supporting the implementation of registration/regulatory strategies for the UCC-SRG portfolios, closely aligned with the region's commercial objectives, to meet EMEA market requirements and (ii) securing local markets by maintaining local licenses compliant with changes related to local/global regulations or changes to the product(s). Responsibilities Drive alignment between regional regulatory strategies and Business Unit and Country RA objectives within BD’s matrix organization. Prepare and compile registration and/or notification dossiers in collaboration with BU and Country RA teams to support timely submissions and renewals. Lead registration planning and prioritization activities in EMEA to ensure strong alignment with business goals. Execute product launch plans, renewals, and amendments, ensuring adherence to regulatory requirements and approved eIPPRA submissions. Conduct impact assessments for product and regulatory changes within EMEA to ensure continued compliance for medical devices and pharmaceutical products. Maintain Regulatory Information Management (RIM) systems, internal registration databases, and tracking tools to ensure data accuracy and transparency. Preferred Qualifications Scientific educational background preferred. 3–5 years of Regulatory Affairs experience, ideally across both Pharmaceutical and Medical Device sectors, with international exposure. Strong organizational, planning, and prioritization skills with the ability to manage multiple tasks. Excellent verbal and written communication skills, with the ability to work cross-functionally and across cultures. High attention to detail with a focus on accuracy and completeness in all regulatory deliverables. Fluent, native-level English proficiency; computer-literate and comfortable working in an international environment. 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 Click on apply if this sounds like you At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. 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: Salary Salary Range Information €36,400.00 - €58,225.00 EUR Annual #J-18808-Ljbffr



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