International Regulatory Affairs Specialist

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. 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) Preferred Qualifications: 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 At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive. We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success. To learn more about BD visit 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, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics. Required Skills Optional Skills . Primary Work Location USA MD - Sparks - 7 Loveton Circle Additional Locations Work Shift NA (United States of America) At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You." Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed. Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role. Salary Range Information $75,800.00 - $121,300.00 USD Annual We are the #MakersofPossible Working together, we make products that patients, families and their healthcare professionals rely on. We do this because we are committed to advancing the world of health™. But it takes the imagination and passion of all of us at BD, from manufacturing to marketing, to look at the impossible and find solutions that turn dreams into possibilities with real-life health benefits for people today, tomorrow and beyond. We make this happen, together. We are the makers of possible. 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, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.