Job Overview
Responsible for supporting and executing regulatory activities across multiple projects and Specimen Management 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.
About the Role
The Regulatory Specialist plays a key role in ensuring compliance with industry standards and regulatory requirements across multiple projects and Specimen Management product lines. This position involves reviewing and approving advertising and promotional materials, managing technical documentation such as Instructions for Use and Declarations of Conformity, and supporting CE marking initiatives for European market access. Acting as a subject matter expert on EU regulations, the role provides guidance to internal teams and serves as the regulatory point of contact for B2B clients and stakeholders.
In addition to product‑specific responsibilities, the Regulatory Specialist leads non‑product regulatory projects, oversees label review processes, and collaborates with cross‑functional teams to support business initiatives. The role also includes providing regulatory input on distribution centre quality processes, supporting partnerships and OEM management, and addressing local regulatory queries to facilitate market access.
Main Responsibilities
* Review and approve advertising and promotional materials to ensure compliance with regulatory legislation, guidelines and company standards.
* Maintain and update the Technical Documentation Repository (including Technical Data Sheet, Instructions for Use, and Declaration of Conformity) to ensure timely, accurate records for internal and external use.
* Address product‑specific regulatory queries from local teams to support market access and compliance; act as the regulatory point of contact for B2B clients and collaborators.
* Lead non‑product regulatory projects and oversee label review and approval processes to ensure alignment with regional and global regulatory standards.
* Collaborate with European distribution centre quality teams to provide regulatory input on CRAF procedures and processes.
* Support regional initiatives for CE marking and other regulatory asks, ensuring products meet all requirements for European market access.
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.
Knowledge and Skills
* Strong understanding of EMEA legislation, standards, and regulatory frameworks, particularly for medical devices, including IVDs, and non‑medical products.
* Proficiency in managing regulatory documentation, labeling requirements, and documentation repositories; high level of accuracy in reviewing and approving labeling, advertising, and promotional materials.
* Ability to lead and manage special projects across regulatory and cross‑functional teams with strong collaborative skills.
* Excellent verbal and written communication skills, conveying regulatory requirements clearly to both technical and non‑technical teams.
* Skilled at resolving compliance issues and responding to complex regulatory queries; flexible in adapting to changing regulatory environments, industry standards, and project demands.
* High proficiency in English, written and spoken.
Compensation
Salary range: €49,100.00 – €83,500.00 EUR annual, determined by experience, education, and skills, as well as applicable labor laws and collective bargaining agreements for the work location.
Equal Opportunity Employer
Becton, Dickinson and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally‑protected characteristics.
Application
Click on “Apply” if you meet the requirements and would like to join BD to help shape the future of health.
Location
BEL Erembodegem - Dorp 86, Spain
Work Arrangement
The position requires a minimum of 4 days of in‑office presence per week. Remote or field‑based arrangements will be detailed in the job posting if applicable.
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