Regulatory Affairs Specialist

Regulatory Affairs Specialist - Regulatory Business SolutionsJob Description Summary :Responsible for supporting and executing regulatory activities across multiple projects and UCC and Surgery product lines to ensure compliance with industry standards and regulatory requirements. This role involves reviewing and approving advertising and promotional materials, managing regulatory and product related documentation, providing local regulatory support, and leading special projects. The Regulatory Specialist works closely with cross‑functional teams to support business initiatives and offer subject matter expertise on EMEA legislation and standards.ResponsibilitiesReview and approve advertising and promotional materials to ensure compliance with regulatory legislations, guidelines and company standards.Maintain and update the Technical Documentation Repository (including Technical Data Sheet, Instructions for Use, Declaration of Conformity, etc.) to ensure timely and accurate records for internal and external needs and requests.Address product‑specific regulatory queries from local teams to support market access and compliance.Lead non‑product‑specific regulatory projects and oversee label review and approval processes to ensure alignment with regional and global regulatory standards.Collaborate with European distribution center quality teams to provide regulatory input on First Article Inspection and CRAF procedures and processes.Support regional initiatives for CE marking and other regulatory asks, ensuring products meet all requirements for European market access.Serve as a subject‑matter expert on EU regulations, offering guidance to internal teams on regulatory standards and compliance issues.Preferred RequirementsExperience with EMEA regulatory standards and CE mark requirements is strongly preferred.Proficiency in managing regulatory documentation, labeling requirements, and documentation repositories; high accuracy in reviewing and approving labeling, advertising, and promotional materials.Excellent verbal and written communication skills, with the ability to convey regulatory requirements clearly to both technical and non‑technical teams; ability to lead and manage special projects across regulatory and cross‑functional teams.Skill at resolving compliance issues and responding to complex regulatory queries; flexibility in adapting to changing regulatory environments, industry standards, and project demands.Strong collaborative skills and a proactive approach to support functions and business‑unit‑specific projects.High proficiency in written and spoken English.Education & ExperienceBachelor’s degree in Life Sciences, Biomedical Engineering, or a related field (Master’s degree preferred).3–5 years of experience in regulatory affairs, preferably within the medical device, pharmaceutical, or life sciences industries.Experience with EMEA regulatory standards and CE mark requirements is strongly preferred.Salary Range€35,000 to €42,000 per year.Company InformationBD 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 The team prioritizes on‑site collaboration to foster creativity, innovation and effective problem‑solving, essential in the fast‑paced healthcare industry. For most roles, we require a minimum of 4 days of in‑office presence per week while recognizing the importance of flexibility and work‑life balance.EEO StatementBecton, 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.Job DetailsSeniority level: Not ApplicableEmployment type: Full‑timeJob function: LegalIndustries: Biotechnology Research, Medical Equipment Manufacturing, and Research Services#J-18808-Ljbffr