Bd
Medical Technology
Principal,MedicalAffairs(PrincipalScientist)
Neural analysis suggests this role is
optimal for Principal candidates.
“Principal, Medical Affairs (Principal Scientist) at Bd. Skills: Medical Affairs, Product development, Clinical studies. Define safety and effectiveness requirements. Implement safety and effectiveness requirements”
Industry & Context.
Troubleshooting; Risk assessment
What They're Looking For.
Must Have
Bachelor of Science (BS) or Master of Science (MS) degree in a health-related field, 2+ years clinical laboratory, clinical research, or related healthcare field experience in a medical device, IVD, or pharmaceutical company
Nice to Have
PhD in a relevant field is desirable, ASCP MLS certification (or equivalent), advanced training or board certification in clinical chemistry, microbiology, molecular biology, or other specialized clinical laboratory relevant experience
What You'll Do.
Define safety and effectiveness requirements
Implement safety and effectiveness requirements
Maintain safety and effectiveness requirements
Lead design of studies
Lead execution of studies
Lead interpretation of studies
Identify new technologies
Evaluate new technologies
Advance new technologies
Establish collaborations with experts
Manage collaborations with experts
Generate clinical evidence
Synthesize clinical evidence
Communicate clinical evidence
Generate technical evidence
Synthesize technical evidence
Communicate technical evidence
Provide technical expertise for marketed products
Provide training for marketed products
Provide troubleshooting support for marketed products
Provide competitive insights for marketed products
Represent Medical Affairs in teams
Review vendor information
Assess risks associated with vendor changes
Review material information
Assess risks associated with material changes
Review manufacturing process information
Assess risks associated with manufacturing process changes
Provide customer expertise
Provide product expertise
Develop safety and effectiveness requirements
Develop clinical test plans
Secure functional approval
Identify new opportunities
Evaluate new opportunities
Present opportunities to business leaders
Ensure safety of products
Ensure effectiveness of products
Ensure clinical utility of products
Interpret medical data
Review scientific data
Interpret scientific data
Interpret study results
Review technical literature
Monitor trends in specimen management
Monitor trends in related technologies
Communicate key findings
Communicate interpretations
Interact with global medical experts
Interact with academic experts
Interact with industry experts
Provide clinical support for products
Provide training for associates
Provide troubleshooting
Provide data interpretation
Provide data presentation
Design post-market studies
Prepare regulatory communications
Review regulatory communications
Address quality-related issues
Design clinical studies
Interpret clinical study findings
Present clinical study findings
Provide medical expertise for HFE studies
Provide leadership for HFE studies
Provide medical expertise for HEOR initiatives
Provide leadership for HEOR initiatives
Provide medical expertise for post-market surveillance
Provide leadership for post-market surveillance
Provide medical expertise for post-market clinical studies
Provide leadership for post-market clinical studies
Prepare technical reports
Prepare journal manuscripts
Present findings at scientific meetings
Present findings at internal BD forums
How You'll Work.
Team & Collaboration
Project teams; Cross-functional partners; Marketing; Regulatory Affairs; Research & Development; Quality; Business leaders; Global medical experts; Academic experts; Industry experts
Communication Scope
Verbal communication; Written communication; Presentation communication
Full 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 **Summary:** 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
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