Risk Management Manager - Vyaire - Irvine, CA

ABOUT THIS ROLE As the Global Process Owner for Risk Management, the Risk Management Manager (RMM) leads Vyaire’s global initiative to ensure full compliance against appropriate and applicable risk management requirements including but not limited to EU MDD 93/42, EU MDR and EN ISO 14971:2012. The RMM drives and supports risk management deliverables as applicable for all pre-launch New Product Introduction (NPI) engineering projects as well as post launch design change projects, including any necessary remediation work related to risk management files (RMF). The RMM may be required to support post market risk assessment activities as required. Reporting to the Senior Manager, Quality Systems - Clinical Risks, the RMM promotes cross functional / business units collaboration, serves as SME for risk management and steward of the process for the company, and is responsible for setting training requirements, driving continuous improvements, providing audit support and resolution of any audit findings related to risk management. In particular you can expect to: Ensure full compliance against applicable regulatory risk management requirements. Recommend appropriate remediation steps and strategies for the identified gaps. Working closely with development and sustaining engineering teams, serve as the risk management SME and participate in engineering meetings to ensure completion of risk management deliverables and ensuring updated RMF is maintained. Recommend any procedural changes related to current effectiveness of risk management process including but not limited to technical reviews, design control practices related to RM plan, RM reviews, RM reports, RMF, and SRA. Monitor and provide Risk Management process performance metrics. Identify and drive process improvements. Demonstrate intermediate knowledge of FDA/ISO requirements. Act as a resource for colleagues with less experience. Comply with Vyaire Medical policies and procedures. You will have the opportunity to: Improve patient outcomes Meaningfully impact the company’s short-term and long-term success Work closely with executives across the organization Grow your role as you see fit Learn everything there is to know about respiratory medical device manufacturing Create an inspiring workplace
To be successful, you will need: Bachelor degree with a technical background. At least 5 years of relevant working experience in medical device industry. Must be familiar with ISO 13485, 14971 and EU MDD 93/42. Must have strong knowledge in respiratory and ventilation products Up to 50% of travel at times may be required. Irvine, CA Full time

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