Remote Senior Director, Post-Market AI & Risk Analytics

Olympus Corporation of the Americas; Westborough (MA); Hybrid; USD 145,000 - 217,000; Full time

Benefits offered by this job

Annual bonus

401(k) with company match

Medical, dental, vision coverage

Employee Assistance Program

Wellbeing programs

Paid vacation and sick time

Parental Leave

Paid holidays

On-site daycare, café, fitness center

Job summary

Olympus Corporation of the Americas is seeking a Senior Director for Post Market Monitoring to lead global surveillance, integrating external data, safety signals, and internal quality data to enhance product performance and patient safety.

The role drives advanced analytics and AI-enabled signal detection within the Quality Management System to support risk assessment, CAPA, and executive decision-making across the product lifecycle.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, Data Science or related technical discipline. Advanced degree strongly preferred.
• Minimum 12 years of progressive experience in medical device Quality/Post Market Surveillance/Risk Management.
• Minimum 7 years of people leadership experience, including management of leaders and dispersed teams.
• Experience developing and implementing global post-market surveillance programs.
• Experience interpreting external safety and market surveillance data to inform risk management.

Responsibilities

• Develop and execute the global strategy for post-market monitoring across all product portfolios.
• Oversee surveillance of regulatory, safety, vigilance, recalls, and adverse event databases.
• Establish systems to monitor internal and external data for emerging trends and risks.
• Lead development of analytics, AI, and data science to improve signal detection and risk prediction.
• Translate data into insights for executive decision-making and CAPA, design controls, and lifecycle management.
• Prepare and maintain PSURs, PMS Plans, and other regulatory submissions.
• Recruit, develop, and lead a high-performing team with scalable processes and governance.
• Foster a culture of quality, compliance, and patient focus.

Skills

Leadership

Strategic thinking

Communication

Cross-functional collaboration

Project management

People management

Regulatory understanding

Education

Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, Data Science or related technical discipline

Advanced degree (MS, MBA, PhD or equivalent) strongly preferred

Job description

Olympus Corporation of the Americas is seeking a Senior Director for Post Market Monitoring to lead global surveillance, integrating external data, safety signals, and internal quality data to enhance product performance and patient safety.

The role drives advanced analytics and AI-enabled signal detection within the Quality Management System to support risk assessment, CAPA, and executive decision-making across the product lifecycle.