Associate Principal Scientist leading device risk management efforts in combination product development. Ensuring delivery of high-quality products and cooperation within cross-functional teams for lifecycle management.
Responsibilities
Responsible for spearheading risk management efforts in combination product development, commercialization, and lifecycle management
Oversee device risk management activities to ensure the delivery of high-quality products and efficient manufacturing processes
Lead and contribute to thorough risk assessments for both inline and new products
Develop and execute the device risk management strategy
Ensure alignment with corporate policies and communicate effectively with cross-functional stakeholders and external suppliers
Support Design Transfer activities
Analyze information from post-market surveillance, clinical evaluations, and real-world evidence to inform risk management decisions and strategies
Work collaboratively with cross-functional teams to embed risk management processes into the overall product development lifecycle
Mentor junior risk management leads and cross-functional partners
Prepare materials for program presentations for management review and regulatory submissions
Requirements
B.S and Master's degree in Engineering, Science, Business, or a related field plus 8 years of related experience
Minimum of 8 years of experience in pharmaceutical development, device development, device systems operations, quality management, or a related area
Strong knowledge of regulatory requirements and industry standards related to device systems
Strong analytical and statistical skills with experience in data interpretation and risk assessment tools
Excellent communication, leadership, and problem-solving skills
Ability to work in a dynamic and fast-paced environment, managing multiple priorities effectively.
Combination Products
Benefits
medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays
vacation
compassionate and sick days
Job title
Associate Principal Scientist – Device Risk Management Lead
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