Sr. International Regulatory Affairs Specialist at BD (Becton, Dickinson and Company) Milpitas, CA

Senior International Regulatory Affairs Specialist – BD (Milpitas, CA) We are seeking a Senior International Regulatory Affairs Specialist to join our Regulatory Affairs team. The role supports the global commercialization of new or modified in vitro diagnostic (IVD) devices, including research use only (RUO) products, by preparing and managing regulatory submissions worldwide. Key Responsibilities Develop and execute international regulatory strategies for IVD device registrations outside the U.S. and EU. Gather information from international counterparts regarding submission pathways and the impact of changes, and support them in global regulatory submissions/approvals. Prepare, coordinate, and manage regulatory submission documents for new products, renewals, and changes to existing products. Ensure compliance with global regulations and guidelines. Lead responses to regulatory agencies during submission and approval processes. Represent Regulatory Affairs in cross‑functional product development teams. Evaluate design, manufacturing, and process changes for global regulatory impact. Review analytical and clinical protocols to ensure appropriate data collection for submissions. Review and approve product labels, labeling, and promotional materials for regulatory compliance. Provide regulatory support during internal and external audits. Conduct regulatory intelligence activities to monitor, analyze, and communicate evolving regulatory requirements in countries outside the U.S. and EU. Maintain awareness of international regulatory trends, guidance documents, and standards relevant to IVDs. Collaborate with regional RA teams and consultants to ensure timely updates and strategic alignment with local regulatory expectations. Required Qualifications Bachelor’s degree in science, math, engineering, or medical fields preferred, or equivalent combination of education and experience. 7+ years of experience in the medical device, diagnostics, biologics, or pharmaceutical industry with a focus on regulatory affairs. 3+ years of related regulatory submission experience from a medical device and/or IVD industry. Ability to work in a fast‑paced environment and manage multiple projects simultaneously. Demonstrated ability to interpret and apply global IVD regulatory requirements. Experience with IVD and/or medical device country registration/submission. Familiarity with ISO13485/900, EUIVDR, and U.S. FDA510 requirements. Experience reviewing and approving product labeling, advertising, and IFU’s. Excellent interpersonal, written, and verbal communication skills. Strong project management skills with the ability to prioritize and multitask. Strong analytical skills and the ability to think critically and solve problems independently. Detail‑oriented with a proactive approach to problem‑solving. Preferred Qualifications Master’s degree or 10+ years of experience preferred. Regulatory Affairs Certification (RAC) a plus. Experience in the medical device industry; other regulated industries considered. Bi‑lingual Chinese/Mandarin (beneficial but not essential). Additional Information For most roles at BD, a minimum of 4 days of in‑office presence per week is required. Remote or field‑based arrangements are specified in the posting. Employment is contingent upon submitting proof of full COVID‑19 vaccination; while testing may be available or required in some locations. Salary $92,700.00 – $152,900.00 USD annually. EEO Statement 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 Dart Solutions