Principal, Medical Affairs (Principal Scientist)

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.

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.

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  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.

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  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.

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  Advanced training or board certification in nursing, clinical chemistry, microbiology, molecular biology, or other specialized clinical laboratory disciplines; relevant experience may substitute for certification

• 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)

• 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.