Principal, Medical Affairs (Principal Scientist)

Job description

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 Preferred Qualifications 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 regulatory requirements for medical devices Communication & Interpretation Ability to interpret complex clinical and scientific information and communicate it clearly and concisely Strong verbal, written, and presentation skills Collaboration & Interpersonal Effectiveness Excellent interpersonal skills, including collaboration, active listening, and conflict resolution Demonstrates empathy and ability to work effectively across cross-functional teams At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. NJ Benefits Disclosure: At BD, we are committed to supporting our associates’ well-being, development, and success through a performance-based culture. For this position, BD offers a competitive compensation package along with the following benefits specific to this role: 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 insurance, Long-term care with life insurance. Other 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, musculoskeletal surgery, cancer treatment, and bariatric surgery benefit. Retirement and Financial Well-being BD 401(k) Plan, BD Deferred Compensation and Restoration Plan, 529 College Savings Plan, financial counseling, Baxter Credit Union (BCU), Daily Pay, college financial aid and application guidance. Life Balance Programs Paid time off (PTO), including all required State leaves, educational assistance/tuition reimbursement, MetLife Legal Plan, group auto and home insurance, pet insurance, commuter benefits, discounts on products and services, Academic Achievement Scholarship, Service Recognition Awards, employer matching donation, workplace accommodations. Other Life Balance