Hiring: Senior Director, Post Market Monitoring Company: Olympus Corporation Location: Westborough, MA Job Posted Time: 2026-09-03 10:44:05 Employment Type: Full-time / Remote Target Skills & Keywords : AI, Digital Transformation, Embedded Systems, Machine Learning, Product Lifecycle Management, R, Regulatory Compliance, Risk Management About the job Experience: •100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. •12 years of progressive experience within medical device Quality, Post Market Surveillance, Product Safety, Risk Management or related function. •7 years of people leadership experience, including management of leaders and geographically dispersed teams. •100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world. Required Skills: •Develop and execute the global strategy, governance model, processes, and operating framework for post-market monitoring of performance and safety across all product portfolios, ensuring compliance with applicable global regulatory requirements and industry best practices. •Lead the development and deployment of advanced analytics, machine learning, artificial intelligence, and data science capabilities to improve signal detection, trend identification, risk prediction, and decision support across post-market surveillance activities. •Provide leadership and oversight for the timely and accurate development, review, approval, and maintenance of Periodic Safety Update Reports (PSURs), post-market surveillance plans, and other required regulatory submissions and documentation. •Recruit, develop, and lead a high-performing team while establishing scalable processes, performance metrics, technology platforms, and governance mechanisms that support a best-in-class post market surveillance and product performance monitoring function. •Foster a culture of quality, compliance and patient focus that promotes transparency, accountability, and risk-based decision-making. Qualifications: •Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, Data Science or related technical discipline. Advanced degree (MS, MBA, PhD or equivalent) in Data Science, Statistics, Predictive Analytics, Artificial Intelligence, Biostatistics or related discipline strongly preferred. •Minimum of 12 years of progressive experience within medical device Quality, Post Market Surveillance, Product Safety, Risk Management or related function. •Minimum of 7 years of people leadership experience, including management of leaders and geographically dispersed teams. •Demonstrated experience developing and implementing global post-market surveillance programs and quality system processes in accordance with FDA, EU MDR, Health Canada, and other applicable regulatory requirements. •Significant experience interpreting and leveraging external safety, vigilance, adverse event, recall, and market surveillance data to inform product risk management and business decision-making. •Demonstrated success implementing advanced analytics, AI, machine learning, business intelligence, or digital transformation initiatives within regulated healthcare environments. •Strong knowledge of risk management methodologies, CAPA systems, complaint handling, design controls, benefit-risk assessment, and product lifecycle management. •Proven ability to influence senior executives and lead complex cross-functional initiatives across global organizations. •Up to 20% travel (domestic & international). •We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture. Compensation: •$144,541 - $216,812 / year •Flexible work environment (work from home / hybrid options) •Competitive salaries, annual bonus and 401(k)* with company match Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!