Principal, Medical Affairs (Principal Scientist)

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 across traditional and emerging scientific domains. The role establishes and manages collaborations with internal and external experts (clinical, academic, regulatory, and industry partners) to support innovation, product development, and business objectives. Additionally, the principal 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 Represent Medical Affairs in Specimen Acquisition (SA) innovation, technology development, product development, and lifecycle management. Identify key trends, unmet needs, and shape strategic direction through engagement with KOLs and industry experts. 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. 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. Review scientific literature, study data, and technical findings; communicate key insights and recommendations to project teams and leadership. 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. Provide clinical support across the product lifecycle, including training, troubleshooting, regulatory input, post‑market activities, and publication development. Provide leadership in Human Factors Engineering (HFE), HEOR, post‑market surveillance, and clinical studies; liaise with KOLs to inform best practices and standards (e.g., CLSI/IFCC). 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+ years of relevant medical device or pharmaceutical company experience may be 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. Preferred Qualifications PhD or doctoral degree in a relevant field. Knowledge of FDA regulations, ISO standards, EU MDR/IVDR, and other industry regulations for medical devices. Familiarity with BD products. Professional certification relevant to medical affairs or quality assurance. Knowledge and interpretation of FDA regulations, ISO standards, EU MDR/IVDR; familiarity with industry standards for medical devices. Knowledge and Skills Strong knowledge of scientific methodologies and 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 regulatory requirements for medical devices. Ability to interpret complex clinical and scientific information and communicate it clearly and concisely. Excellent verbal, written, and presentation skills. Collaboration, active listening, conflict resolution, and empathy for cross‑functional teamwork. Benefits Annual bonus. Health and well‑being benefits: medical coverage, Health Savings Accounts, Flexible Spending Accounts, dental coverage, vision coverage, hospital care insurance, critical illness insurance, accidental injury insurance, life and AD&D insurance, short‑term disability coverage, long‑term disability coverage, long‑term care with life insurance. Well‑being resources: anxiety management program, wellness incentives, sleep improvement program, diabetes management program, virtual physical therapy, emotional/mental health support programs, weight management programs, gastrointestinal health program, substance use management program. Retirement and financial well‑being: 401(k) plan, deferred compensation, restoration plan, 529 College Savings Plan, financial counseling, Baxter Credit Union, Daily Pay. Life balance programs: PTO, state leaves, educational assistance, MetLife Legal Plan, group auto and home insurance, pet insurance, commuter benefits, discounts on products, academic achievement scholarship, service recognition awards, employer matching donation, workplace accommodations, adoption assistance, backup day care and eldercare, support for neurodivergent adults, children, caregivers, EAP, paid parental leave, support for fertility, birthing, postpartum, and age‑related hormonal changes. Leave programs: Bereavement, military, personal, Family and Medical Leave (FML), Jury and Witness Duty Leave. Salary $135,500.00 – $216,800.00 USD per annum. 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 Becton Dickinson