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About the role
Key responsibilities & impact- Provide medical and scientific support for new product development from concept through commercialization
- Provide medical support to the Office of the Chief Medical Officer, including representation at medical conferences, sales meetings, and physician/hospital interactions
- Develop medical assessment documents, scientific reviews, medical opinions, and clinical evidence summaries
- Serve as a clinical subject matter expert on laboratory medicine, diagnostic testing practices, healthcare workflows, and customer needs
- Ensure clinical and medical requirements are incorporated into product design and design-control activities
- Evaluate clinical risks and provide recommendations for safe and effective product development
- Participate in medical oversight for product performance, post-market surveillance, and patient safety
- Review product complaints, Medical Device Reports (MDRs), adverse-event trends, and other post-market data
- Conduct or support Health Hazard Evaluations (HHEs), medical risk assessments, and benefit-risk analyses
- Partner with Quality and Regulatory Affairs to investigate product performance issues and determine corrective actions
- Strengthen medical risk-management and product-safety monitoring processes
- Provide medical input into clinical study design, protocol development, and clinical risk mitigation
- Review clinical data and product performance information for regulatory submissions and post-market activities
- Support interactions with the FDA and international health authorities
- Support compliance with global regulations, quality standards, and medical-device reporting requirements
- Recommend enhancements to product monitoring, safety assessments, and risk-evaluation methodologies
- Assess the clinical significance and patient, provider, and laboratory impact of product-performance findings
- Present medical assessments, risk evaluations, and scientific recommendations to leadership and cross-functional stakeholders
- Represent Medical Affairs at scientific meetings, customer interactions, physician engagements, industry conferences, and internal business meetings
Requirements
What you’ll need- Bachelor’s degree with some advanced degree in Clinical Laboratory Science
- Advanced degree may offset required years of experience
- Equivalent combination of education and work experience; Doctorate Degree (±19 years)
- Advanced degree; MD preferred
- Minimum 5 years of clinical laboratory experience
- Minimum 10 years of related work experience
- Experience in laboratory settings in a healthcare environment is ideal
- Clinical experience as NP, MD, or DO
- Ability to evaluate clinical and product performance data
- Knowledge of post-market surveillance, medical device reporting (MDR), clinical research, and regulatory requirements
- Understanding of product development, risk management, and regulatory requirements within the healthcare or diagnostic industry
- Ability to work across scientific, technical, and business functions
- Ability to communicate complex medical and scientific information to technical and non-technical audiences
- Work with human blood or other potentially infectious materials
- Work with infectious organisms or known infectious materials
- Work with or near radiation sources and/or radioactive material
Benefits
Comp & perks- Career development with an international company
- Free medical coverage eligibility through the Health Investment Plan (HIP) PPO medical plan in the next calendar year
- Excellent retirement savings plan with a high employer contribution
- Tuition reimbursement
- Freedom 2 Save student debt program
- FreeU education benefit for an affordable path to a bachelor’s degree
- Travel at 10% of the time