Principal, Medical Affairs (Principal Scientist)

Requirements

• A PhD or doctoral degree in a relevant field is desirable
• Knowledge, understanding, and interpretation of FDA regulations, ISO standards, EU MDR/IVDR, and other industry standards for medical devices or similar industry
• Familiarity with BD products
• Professional certification (type not specified, but likely relevant to medical affairs or quality assurance)
• Knowledge and Skills
• Scientific, Clinical & Regulatory Expertise
• Strong knowledge of scientific methodologies and their application in clinical laboratory medicine
• Solid understanding of clinical study design, execution, data analysis, and interpretation
• Knowledge of best practice standards and guidelines for specimen management (e.g., CLSI, IFCC)
• Understanding of MDR, FDA, and global regulato

Benefits

Additional Information

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 Principal, Medical Affairs The principal is responsible for defining, implementing, and maintaining safety and effectiveness (S&E) requirements for both current and future products. This role leads the design, execution, and interpretation of feasibility, clinical, and human factors studies, serving as a key scientific and technical authority across project teams and cross-functional partners including Marketing, Regulatory Affairs, Research & Development, and Quality. The principal identifies, evaluates, and advances new technologies and customer solutions, spanning both traditional and emerging scientific domains. The role also establishes and manages collaborations with internal and external experts (e.g., clinical, academic, regulatory, and industry partners) to support innovation, product development, and business objectives. Additionally, the Principal Scientist generates, synthesizes, and communicates clinical and technical evidence to support innovation strategies, product development, regulatory submissions, and product lifecycle management. For marketed Specimen Acquisition (SA) products, the principal provides ongoing technical expertise, training, troubleshooting support, and competitive insights to ensure continued product performance and customer satisfaction. Duties and Responsibilities : Medical Affairs Representation & Strategy Represent Medical Affairs in Specimen Acquisition (SA) innovation, technology development, product development, and lifecycle management. Identify key trends, unmet needs, and help shape strategic direction through engagement with KOLs and industry experts. Innovation & Cross-Functional Collaboration Partner with cross-functional teams to identify, evaluate, and advance new opportunities through the innovation process. Provide product, customer, and clinical expertise to support development and business decisions. Clinical & Scientific Evidence Generation Design and lead clinical, analytical, and feasibility studies, including commutability and bridging strategies. Develop safety and effectiveness requirements and clinical test plans to support regulatory and marketing needs. Data Review & Communication Review and interpret scientific literature, study data, and technical findings. Communicate key insights and recommendations to project teams and leadership. Risk Management & Product Assurance Evaluate and manage risks related to design changes, NPD, and vendor/material/manufacturing process changes. Ensure safety, effectiveness, and clinical utility of products, labeling, and promotional materials. Product Support & Lifecycle Management Provide clinical support across the product lifecycle, including training, troubleshooting, regulatory input, post-market activities, and publication development. Medical Expertise & Leadership Provide leadership in Human Factors Engineering (HFE), HEOR, post-market surveillance, and clinical studies. Act as or liaise with KOLs to inform best practices, standards (e.g., CLSI/IFCC), and clinical insights. Minimum Requirements Master of Science (MS) degree or PhD in a health-related field, such as Biochemistry, Chemistry, Microbiology, Molecular Biology, Nursing, or similar disciplines. Bachelor of Science (BS) with 5 plus years of relevant medical device or pharmaceutical company experience maybe considered. 5+ years in either clinical laboratory, clinical research, or related healthcare field experience; experience in a medical device, IVD, or pharmaceutical company is a plus. Advanced training or board certification in nursing, clinical chemistry, microbiology, molecular biology, or other specialized clinical laboratory disciplines; relevant experience may substitute for certification

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