Senior Director, Post-Market AI & Risk (Remote)

Olympus Corporation; Westborough (MA); Hybrid; USD 144,541 - 216,812; Full time

Benefits offered by this job

Competitive base pay

401(k) with company match

Medical, dental, vision coverage

Paid time off and holidays

Parental leave

Job summary

Olympus Corporation is seeking a Senior Director of Post Market Monitoring to lead the design and integration of advanced surveillance systems. You will oversee external and internal data integration, drive AI-enabled analytics, and ensure alignment with the Quality Management System to mitigate product risk and improve patient safety.

The role requires extensive experience in PMS, risk management, and cross-functional leadership across global teams, with travel up to 20%.

Qualifications

• Bachelor’s degree in a technical field; advanced degree preferred (MS/MBA/PhD).
• 12+ years in medical device quality, PMS, risk management or related.
• 7+ years of people leadership across global teams.
• Experience implementing global PMS programs compliant with FDA/EU MDR.

Responsibilities

• Develop global post-market monitoring strategy and governance across product portfolios.
• Oversee surveillance of regulatory and safety databases to identify emerging risks and trends.
• Lead AI/ML-enabled analytics to improve signal detection and risk prediction.
• Drive integration of external and internal data sources to support risk management and decision-making.

Skills

Leadership

AI & ML

Data Analytics

Risk Management

Cross-functional Collaboration

Education

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

Job description

Olympus Corporation is seeking a Senior Director of Post Market Monitoring to lead the design and integration of advanced surveillance systems. You will oversee external and internal data integration, drive AI-enabled analytics, and ensure alignment with the Quality Management System to mitigate product risk and improve patient safety.

The role requires extensive experience in PMS, risk management, and cross-functional leadership across global teams, with travel up to 20%.