International Regulatory Affairs Specialist

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.
• Minimum Requirements
• Education & Experience:
• 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).
• Technical & Functional Skills:
• 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
• Communication & Collaboration:
• Strong written and verbal communication skills
• Experience working with global teams, regional affiliates, or distributors
• Process & Compliance:
• Familiarity with SOPs, regulatory procedures, and quality systems (e.g., ISO 13485)
• Ability to identify and support process improvements
• Other:
• Strong organizational skills and ability to manage multiple submissions/projects simultaneously
• Proficiency in Microsoft Office tools (Excel, Word, PowerPoint)

Requirements

• 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
• Preferred Regulatory Knowledge:
• Working knowledge of global regulatory requirements (e.g., EU MDR/IVDR, Canada, LATAM, APAC markets)
• Familiarity with technical documentation, dossiers, and clinical evaluation reports

Benefits

Additional Information

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters' innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters' passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide. We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. 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 look at the impossible and find transformative solutions that turn dreams into possibilities. Job Description 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.

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