Research Assistant providing patient care activities and supporting research projects at Cleveland Clinic. Collaborating with a team to ensure effective delivery of study - related tasks.
About the role
- 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
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