Job Description

As Staff Regulatory Affairs Specialist, you will be responsible for supporting MMS Dispensing products consisting of Medical Devices and Non-Medical Devices along with associated Software and Accessories on a global basis from a Regulatory Affairs standpoint. Support will consist of new product development, sustaining, and end of life activities. Candidates must be able to work in our San Diego, CA office 4 days per week. Primary Responsibilities include supporting regulatory efforts to comply with new and existing regulations (e.g., FDA Medical Device Regulations, EU-MDR), problem solving and escalating regulatory and compliance issues to senior management as necessary, driving continuous improvement in internal processes and customer satisfaction, supporting the monitoring and interpreting of current and new regulatory requirements and international standards for U.S. and RoW, ensuring QMS requirements are followed and executed consistently from RA perspective, supporting efforts for Technical File creation, remediation, and collaboration with cross-functional teams for required content, supporting regulatory impact assessments for change controls and other RA/QA items from a review and approve level, assisting in preparing, auditing, editing, and publishing registration documentation as needed, supporting business export control (BEC) listing of product for release globally per RA requirements, and supporting the review and approval of product labeling, promotional, and advertising materials as needed. Candidates should have a minimum bachelor’s degree in RA, QA, engineering, or other science-related discipline, with an advanced degree preferred. RAPS RAC certification is preferred. Minimum of 5 years of strong Regulatory Affairs/Compliance experience in medical devices is required. Experience with end-to-end SAMD new product development, sustaining and end of life activities including experience on new labeling creation, risk management file review and inputs is needed. Knowledge of global Regulatory Affairs requirements, regulations, and standards is essential. Strong prioritizing, interpersonal, communication, and analytical skills, and the ability to multi-task disparate projects are required. The role emphasizes on-site collaboration with a minimum of 4 days in-office presence per week in San Diego, CA. The company is Becton, Dickinson and Company, a global medical technology company committed to advancing health and fostering a culture of learning, growth, and innovation.

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