Associate Specialist, Regulatory Affairs

About BD 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. Role Overview The Advanced Patient Monitoring Regulatory Affairs team is seeking a detail‑oriented and proactive Regulatory Affairs Associate Specialist to support global product distribution and ensure ongoing regulatory compliance. In this role, you will play a key part in maintaining and optimizing internal distribution‑control processes, product data management, and regulatory systems, including support for transitional distribution‑control activities across the Regulatory Affairs team. This role is responsible for managing product data attributes, certificates, and country‑specific compliance requirements within internal product data management, distribution‑control, and regulatory information management systems. You will ensure products meet all applicable regional regulatory requirements and that accurate, validated data supports global commercialization activities, including submissions to regulatory databases such as GUDID and EUDAMED. In this position, you will maintain accurate product and regulatory data to safeguard global distribution and ensure adherence to local, regional, and international regulatory standards. The role requires close collaboration with cross‑functional teams, including Master Data Management, Corporate and Business Unit Regulatory Affairs, International RA, Supply Chain, Labeling, Marketing, IT/System Administrators, and Quality. This role provides an excellent opportunity for a detail‑oriented data steward with strong analytical skills to contribute meaningfully to the success of the Advanced Patient Monitoring business by ensuring the accuracy, integrity, and compliance of critical product and regulatory data. Key Responsibilities Collaborate with the Regulatory Affairs team to ensure accurate and compliance product information. Partner with Master Data Management, Corporate RA, Advanced Patient Monitoring (APM) RA, In‑Country RA, Supply Chain, Marketing, Labeling and Quality to maintain high‑quality product data. 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. Perform data entry, data validation, tracking, and reporting within regulatory systems. Develop expertise as a power user of internal product data management and distribution‑control systems. Provide subject‑matter expertise, data collection support, and submission coordination for system users. Collect, analyze, and interpret data to generate accurate reports and insights. Conduct ad hoc queries and support a variety of data‑driven projects. Review existing processes, systems, and documentation to identify and recommend improvement opportunities. Contribute to the design, testing, and rollout of system updates and enhancements. Troubleshoot issues, elevate concerns as appropriate, and collaborate closely with IT/system support teams. Work effectively with global partners and flex working hours when needed to support international collaboration. Required Qualifications Strong attention to detail with excellent analytical and problem‑solving skills. Proficiency in Excel and data manipulation tools. Demonstrated accountability and ownership of assigned work. Self‑motivated with a positive, proactive, and learning‑oriented mindset. Ability to manage multiple priorities, timelines, and stakeholders effectively. Results‑driven, diligent, and able to work independently. Comfortable multitasking in a dynamic environment with evolving needs. Strong written and verbal communication skills. Preferred Qualifications Bachelor’s degree in a scientific, engineering, or regulatory field (or equivalent experience). Demonstrated ability to learn quickly and adapt to new systems, tools and processes. Experience working in regulatory or compliance‑driven environments. Knowledge of EU MDR/MDD, FDA medical device regulations, and other international regulatory frameworks. Proven experience collaborating with cross‑functional teams in a regulated environment. 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 processes, and country‑specific licensing. Working knowledge of ERP system execution and workflows (e.g., SAP). Location and Salary Primary Work Location: USA CA - Irvine Laguna Canyon Salary Range: $33.80 - $55.80 USD hourly Workplace Policy For most roles, we require a minimum of 4 days of on‑site 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. Equal Opportunity Employer 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 BD Mexico