Regulatory Affairs Specialist
hace 4 días
Regulatory Affairs Specialist – Regulatory Business SolutionsBD Nogales NorteRegulatory 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, overseeing 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 level of 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.Skilled at resolving compliance issues and responding to complex regulatory queries.Flexible 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 English written and spoken.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 €42,000Legal & 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.#J-18808-Ljbffr
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Regulatory Affairs Specialist
hace 4 días
L'Hospitalet de Llobregat, España BD Nogales Norte A tiempo completoA leading medical device company in l'Hospitalet de Llobregat is seeking a Regulatory Affairs Specialist to manage regulatory activities and ensure compliance with industry standards. The role requires strong expertise in EMEA regulations and collaboration with cross-functional teams. Candidates should have 3-5 years of experience in regulatory affairs,...
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Regulatory Affairs Specialist
hace 4 días
L'Hospitalet de Llobregat, España BD A tiempo completoA global medical technology company is seeking a Regulatory Affairs Specialist to support regulatory activities across multiple projects and product lines. The role focuses on ensuring compliance with industry standards and regulatory requirements by reviewing and approving promotional materials, managing documentation, and providing support to...
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Regulatory Affairs Specialist
hace 5 días
L'Hospitalet de Llobregat, España BD A tiempo completoA global medical technology company is seeking a Regulatory Affairs Specialist to support regulatory activities across multiple projects and product lines.¿Es este su próximo empleo? Descúbralo leyendo la descripción completa a continuación y no dude en enviar su candidatura.The role focuses on ensuring compliance with industry standards and regulatory...
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Regulatory Affairs Specialist
hace 4 días
L'Hospitalet de Llobregat, España BD A tiempo completoRegulatory 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...
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l'Hospitalet de Llobregat, España BD A tiempo completo**Job Description Summary**: Join the Regulatory Affairs Business Solutions team for the MDS (Medication and Delivery Solutions) and MMS (Medication Management Solutions) businesses in the EMEA region. You will contribute to regulatory activities for BD’s largest product portfolio. The RA trainee will be responsible for supporting regulatory activities...
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