Principal, Medical Affairs (Principal Scientist)

About the role

The Principal Medical Affairs associate 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 Medical Affairs associate 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, this role generates, synthesizes, and communicates clinical and technical evidence to support innovation strategies, product development, regulatory submissions, and product lifecycle management. For marketed Specimen Management (SM) products, the role provides ongoing technical expertise, training, troubleshooting support, and competitive insights to ensure continued product performance and customer satisfaction. Job Responsibilities Represents Medical Affairs in Specimen Management (SM) innovation, technology development, product development, and product lifecycle management teams. Identifies key trends and unmet needs in science, technology, medical practice, and health economics. Reviews information and assesses risks associated with vendor, material, and manufacturing process changes. Provides customer and product expertise to project teams. Develops safety and effectiveness (S&E) requirements and a clinical test plan to meet Regulatory and Marketing needs for new and improved products, and secures functional approval. Works with cross-functional partners to identify and evaluate new opportunities and present them to business leaders through the formal Innovation process. Ensures the safety, effectiveness, and clinical utility of products, technologies, and related labeling/promotional materials. Reviews and interprets medical and scientific data, study results, and technical literature. Monitors trends in specimen management and related technologies. Communicates key findings and interpretations to teams and management. Interacts with global medical, academic, and industry experts to help establish strategic direction for innovation, technology development, and product development initiatives. Provides clinical support for products entering the market or currently marketed, including training BD associates, troubleshooting, data review, interpretation and presentation, post-market study design, publication development, preparation or review of regulatory communications, and addressing quality-related issues. Designs studies and leads scientific investigations, feasibility assessments, and due‑diligence evaluations related to new technologies and products. Prepares technical reports, abstracts, journal manuscripts, and presents findings at scientific meetings or internal BD forums. Reviews information and assesses risks associated with vendor, material, and manufacturing process changes. Designs clinical studies as needed and interprets and presents findings. Provides medical expertise and leadership for Human Factors Engineering (HFE) studies, Health Economics & Outcomes Research (HEOR) initiatives, post‑market surveillance, and post‑market clinical studies. Education and Experience: Bachelor of Science (BS) or Master of Science (MS) degree in a health-related field, such as Biochemistry, Chemistry, Microbiology, Molecular Biology, Nursing, or similar disciplines. A PhD in a relevant field is desirable. 2+ years of clinical laboratory, clinical research, or related healthcare field experience; experience in a medical device, IVD, or pharmaceutical company is a plus. ASCP MLS certification (or equivalent), or advanced training or board certification in clinical chemistry, microbiology, molecular biology, or other specialized clinical laboratory disciplines; relevant experience may substitute for certification. Knowledge and Skills Knowledge of scientific methodologies and their application in clinical laboratory medicine. Solid understanding of clinical studies, including study design, execution, data interpretation, and analysis. Exceptional