[Hiring] Senior Director, Post Market Monitoring @Olympus Corporation of the Americas

Role Description

The Senior Director, Post Market Monitoring is accountable for developing and integrating advanced post market surveillance systems that combine external market intelligence, publicly available safety and regulatory data, scientific literature, real-world evidence, and internal quality data sources to generate actionable insights that improve product performance, patient safety, and regulatory compliance. The Senior Director will lead the implementation of AI-enabled analytics and signal detection capabilities that transform structured and unstructured data into meaningful risk intelligence, enabling the organization to identify trends, emerging risks, and new use cases before they escalate into significant quality, regulatory, or business risks. The role will ensure these capabilities are embedded within the Quality Management System and effectively support risk management, CAPA, design controls, product lifecycle management, and executive decision-making.

Job Duties

• 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.
• Oversee systematic surveillance of publicly available regulatory, safety, vigilance, recall, and adverse event databases, including competitor and product-category performance data, to identify emerging risks, market trends, and industry-wide safety concerns relevant to company products.
• Ensure effective integration of these external sources with internal data sources including but not limited to complaint, field service, technical support, medical safety, clinical, manufacturing, and R&D to provide a comprehensive view of product performance and risk across the product lifecycle.
• Establish systems and processes that continuously aggregate, monitor, and analyze internal and external data to identify emerging trends, risks, safety signals, and opportunities for proactive intervention.
• Ensure these systems and processes drive timely identification, assessment, escalation, and mitigation of emerging product quality, safety, clinical, and usability risks before they result in significant patient, customer, regulatory, or business impact.
• 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.
• Translate complex data into meaningful product performance insights, risk assessments, and recommendations that inform executive decision-making, risk management activities, CAPA, design controls, complaint investigations, and product improvement initiatives.
• Partner with other Post Market Surveillance functions, Medical Safety, Infection Prevention Control, Manufacturing, R&D, Supplier Quality and Business leaders to drive accountability across the organization to ensure timely actions to mitigate risk.
• 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.
• Experience integrating multiple internal and external data sources to identify trends, safety signals, and emerging product performance risks.
• 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.
• Experience preparing, reviewing, or overseeing PSURs, PMS Plans, post-market studies, and other global post-market surveillance deliverables.
• Proven ability to influence senior executives and lead complex cross-functional initiatives across global organizations.
• Experience building, developing, and leading high-performing technical and analytical teams.
• Up to 20% travel (domestic & international).

Benefits

• Competitive salaries, annual bonus and 401(k)* with company match
• Comprehensive medical, dental, vision coverage effective on start date
• 24/7 Employee Assistance Program
• Free live and on-demand Wellbeing Programs
• Generous Paid Vacation and Sick Time
• Paid Parental Leave and Adoption Assistance*
• 12 Paid Holidays
• On-Site Child Daycare, Café, Fitness Center**

Company Description

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives. Our five Core Values empower us to achieve Our Purpose: Patient Focus, Integrity, Innovation, Impact and Empathy.