Job Title Risk Management Officer
Job Title : Risk Management Officer
Job Responsibilities:
Manages the product development cross-functional team responsible for creating and/or approving all risk management deliverables for one complex or multiple simple products throughout its' lifecycle.
Provides business-level guidance on product hazards and harms and collaborates with medical affairs to ensure identification of harms and alignment with applicable regulations and standards, aiming to mitigate risks and safeguard patient, user and consumer safety.
Participates in process improvement initiatives to enhance efficiency and effectiveness in risk management, striving for best-in-class practices by identifying and implementing enhancements that streamline processes and improve overall performance in managing and mitigating risks.
Manages one or more junior team members in product risk management, guides their development, ensures adherence to risk management practices, and coordinates their efforts to support effective risk assessment and mitigation across product lines.
Monitors key performance indicators (KPIs) pertaining to product risk management processes, assisting senior risk managers in facilitating informed decision-making and strategic planning within the department to ensure optimal performance and compliance with regulatory standards.
Monitors and maintains vigilant oversight of regulatory and standard requirements and implements necessary measures to uphold safety standards to ensure compliance with product safety regulations and standards.
Acts accountable for low-to-medium complexity product risk management inquiries, participates in teams conducting investigations, and effectively communicates risk findings and recommendations to senior risk management for informed decision-making and ensures proactive risk mitigation strategies are developed to maintain patient, user and consumer safety.
Implements effective risk assessment methodologies to comprehensively evaluate potential hazards associated with products, facilitating informed decision-making and proactive mitigation strategies.
Manages targeted components within larger change initiatives, ensures the proactive identification, analysis, and mitigation of potential risks associated with product development, deployment, and lifecycle management, thereby safeguarding organizational objectives and optimizing outcomes.
Minimum required Education:
Bachelor's/Master's Degree in Medical Sciences, Engineering, Life or Physical Science, Computer Science/Software development or equivalent.
Minimum required Experience:
Minimum 8-10 years of experience with Bachelor's degree in areas such as Medical Device Product Development, Post Market Surveillance, Quality Engineering or equivalent.
Preferred Skills:
Product Risk Management - Mandatory
Post-Market Surveillance Mechanisms
Quality Management Systems (QMS)
Quality Specifications
CAPA Methodologies
Continuous Improvement
Regulatory Compliance
Reliability Engineering
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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