International Regulatory Affairs Specialist

Becton Dickinson Medical Devices•Sparks, NV

1d•Onsite

About The Position

The International Regulatory Affairs Specialist is responsible for collaborating with regional colleagues to develop strategies for moderately complex submissions to regulatory agencies worldwide. They interpret regulations and guidance’s ex-U.S. and communicate to the country how these impact the ability to register. They coordinate and support worldwide product registration requests, interface with global international regulatory and marketing contacts to support regional registration requirements and develop/maintain department procedures for international product registrations. They assemble technical information according to registration requirements. They understand the regulations of the regions and how to meet their registration needs as well as the objectives of the business.

Requirements

Bachelor’s degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, Pharmacy, or related scientific/technical discipline (Equivalent combination of education and relevant experience may be considered).
Experience coordinating cross-functional inputs (R&D, QA, Manufacturing, Marketing)
Ability to compile and review technical documentation in accordance with country-specific requirements
Understanding of regulatory submission processes and lifecycle management
Strong written and verbal communication skills
Experience working with global teams, regional affiliates, or distributors
Familiarity with SOPs, regulatory procedures, and quality systems (e.g., ISO 13485)
Ability to identify and support process improvements
Strong organizational skills and ability to manage multiple submissions/projects simultaneously
Proficiency in Microsoft Office tools (Excel, Word, PowerPoint)

Nice To Haves

Experience supporting international (ex-U.S.) regulatory submissions and product registrations
Minimum 2–5 years of regulatory affairs experience, preferably in medical devices, pharmaceuticals, or healthcare products
Regulatory Affairs Certification (RAC)
Experience acting as country lead or project lead for registrations
Exposure to OEM/private label compliance requirements
Knowledge of UDI, labeling, and post-market regulatory activities
Working knowledge of global regulatory requirements (e.g., EU MDR/IVDR, Canada, LATAM, APAC markets)
Familiarity with technical documentation, dossiers, and clinical evaluation reports

Responsibilities

Coordinates and collects specific registration information with R&D, Manufacturing, QA, Medical and other applicable departments, as necessary to support registration requirements.
Interfaces with OEMs to collect specific registration information.
Assembles technical information to create a "clinical report" or a "dossier".
Acts as lead for key countries, as identified, managing each request to completion.
Recognizes and proposes continuous process improvements.
Develops and maintains departmental procedures (SOP's and work instructions) for international product registrations.