Specialist, Regulatory Affairs

Role Overview The Advanced Patient Monitoring Regulatory Affairs team is seeking a detail-oriented and proactive Regulatory Affairs Specialist to support global product distribution and ensure ongoing regulatory compliance. This role maintains high‑quality regulatory and product data across internal systems, enabling compliant global commercialization and lifecycle management. Key Responsibilities Ensure data accuracy, consistency, and traceability to support global registrations, product releases, and lifecycle changes. Partner with Regulatory colleagues to maintain regulatory and product data used for submissions to external regulatory databases, including GUDID and EUDAMED. Perform routine data entry, validation, reconciliation, tracking, and reporting activities to support audits, inspections, and internal reviews. Identify opportunities to improve data quality, efficiency, and regulatory data governance. Support the implementation and ongoing maintenance of new transitional distribution‑control processes. Coordinate with cross‑functional teams to enable the timely and compliant release of products. Monitor data dependencies and identify risks or issues that could impact product availability or regulatory compliance. Partner closely with Master Data Management, Corporate RA, Advanced Patient Monitoring (APM) RA, In‑Country RA, Supply Chain, Marketing, Labeling, Quality and IT/System Administration teams to maintain high‑quality product data. Serve as a knowledgeable resource for regulatory and product data questions related to products or systems. Work with global partners and flex working hours when needed to support international collaboration. Act as a power user of regulatory and product data systems; provide guidance and support to other system users. Provide subject‑matter expertise, data collection support, and submission coordination for system users. Collect, analyze, and interpret data to generate reports, metrics, and insights for stakeholders. Support ad hoc data requests and data‑driven projects. Review existing processes, systems, and documentation to identify and recommend improvement opportunities. Contribute to system enhancements, testing, and process improvements. Troubleshoot data or system issues, escalating appropriately, and collaborating with IT/system support teams. Required Qualifications Strong attention to detail with excellent analytical, problem‑solving and organizational skills. Proficiency in Excel and data manipulation or reporting tools. Demonstrated ownership and accountability for assigned work. Self‑motivated, proactive, and adaptable with a continuous learning mindset. Ability to manage multiple priorities and stakeholders in a fast‑paced, regulated environment. Results‑driven, diligent, and able to work independently. Strong written and verbal communication skills. Preferred Qualifications Bachelor’s degree in a scientific, engineering, or regulatory field (or equivalent experience). Minimum of 3 years of experience in regulatory affairs, regulatory operations, data management, or a compliance‑driven environment. Demonstrated ability to learn quickly and adapt to new systems, tools and processes. Knowledge of EU MDR/MDD, FDA medical device regulations, and other international regulatory frameworks. Prior experience with product data management, ERP, or distribution control systems. Experience with Master Data Management principles and tools. Familiarity with UDI requirements, CE marking, and country‑specific licensing processes. Working knowledge of ERP system execution and workflows (e.g., SAP). Proven ability to collaborate cross‑functionally in a global, regulated organization. This role requires Independent judgment, regulatory data expertise, and collaboration across functions. The role may provide guidance or informal mentoring to peers but does not include people‑management responsibilities. Salary Range $80,600.00 - $133,000.00 USD Annual Primary Work Location USA CA - Irvine Laguna Canyon Additional Locations DOM San Cristobal - Nave 25-Merengue Equal Employment Opportunity 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. #J-18808-Ljbffr