Regulatory Affairs Specialist - Regulatory Business Solutions

Regulatory Affairs Specialist - Regulatory Business Solutions

BD Nogales Norte is looking for a Regulatory Affairs Specialist to support and execute regulatory activities across multiple projects in the UCC and Surgery product lines, ensuring compliance with industry standards and regulatory requirements.

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

Education and Experience

Salary Range

€35,000 to €42,000 annually

Why Join Us?

BD is one of the largest global medical technology companies in the world. “Advancing the world of health”™ is our purpose, and 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 turn dreams into possibilities.

You will learn, grow, and thrive in an inclusive, growth‑centered, and rewarding culture and help shape the trajectory of BD while leaving a legacy.

EEO Statement

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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