Waters
Life Sciences
InternationalRegulatoryAffairsSpecialist
Neural analysis suggests this role is
optimal for Mid+ candidates.
“International Regulatory Affairs Specialist at Waters. Skills: Regulatory affairs, Product registration, Global regulations. Collaborate with regional colleagues to develop strategies. Interpret regulations and guidance's ex-U. S.”
Industry & Context.
Process improvement
What They're Looking For.
Must Have
Bachelor's degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, Pharmacy, or related scientific/technical discipline, Experience coordinating cross-functional inputs, Ability to compile and review technical documentation, Understanding of regulatory submission processes, Written and verbal communication skills, Experience working with global teams, Familiarity with SOPs, regulatory procedures, and quality systems, Ability to identify and support process improvements, Organizational skills, Ability to manage multiple submissions/projects simultaneously, Proficiency in Microsoft Office tools
Nice to Have
Experience supporting international regulatory submissions, 2–5 years of regulatory affairs experience, Regulatory Affairs Certification (RAC), Experience acting as country lead, Experience as 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, Familiarity with technical documentation, dossiers, and clinical evaluation reports
What You'll Do.
Collaborate with regional colleagues to develop strategies
Interpret regulations and guidance's ex-U. S.
Communicate regulatory impact to country
Coordinate and support worldwide product registration requests
Interface with global international regulatory and marketing contacts
Develop/maintain department procedures for international product registrations
Assemble technical information according to registration requirements
Understand regional regulations and business objectives
Coordinate and collect specific registration information
Interface with OEMs to collect specific registration information
Assemble technical information to create a clinical report
Act as lead for key countries
Manage each request to completion
Recognize and propose continuous process improvements
Develop and maintain departmental procedures (SOP's and work
How You'll Work.
Team & Collaboration
Cross-functional teams; Global teams; Regional affiliates; Distributors
Communication Scope
Written communication; Verbal communication
Process & Methodology
Project management
Full Job Description
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 r
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