Risk Management Officer

2 weeks ago


Bengaluru India Respironics Inc Full time

Job Description Job Title Risk Management Officer Job Description 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. . Learn more about . . Discover . . Learn more about . How we work at Philips Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart Our commitment to inclusion and diversity At Philips, we provide equal opportunities to all our employees and to all eligible applicants for employment in our company , irrespective of age, color, disability, nationality, race, religion, gender, sexual orientation (LGBTQ +), and all aspects that make individuals unique. Encouraging diversity and fostering inclusion are key to our mission of improving the lives of 2.5 billion people a year by 2030 through meaningful innovation. We have fair, transparent, and clear employee policies which promote diversity and equality, in accordance with currently applicable law. For, we believe that life is better when #youareyou. Our hybrid working model is defined in 3 ways: There's a certain energy when everyone's in the same room that can heighten idea generation and creative friction needed for problem-solving. Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn't office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis. The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best. Why should you join Philips Working at Philips is more than a job. It's a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you. #LI



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