Regulatory Affairs Specialist - Regulatory Business Solutions
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.
Responsibilities
* Review 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,…) 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, 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 Requirements
* Experience 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 and Experience
* Bachelor’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.
Location: Madrid, Community of Madrid, Spain
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.
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