Senior Director, Post Market Monitoring

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

Working Location: Massachusetts, Westborough
Workplace Flexibility: Remote
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.
Learn more about Life at Olympus: https://www.olympusamerica.com/careers .
Job DescriptionThe 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.

Job Qualifications
Required:

• 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).

Why join Olympus?
We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.
Equitable Offerings you can count on:

• 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**

Connected Culture you can embrace:

• Work-life integrated culture that supports an employee centric mindset
• Offers onsite, hybrid and field work environments
• Paid volunteering and charitable donation/match programs
• Employee Resource Groups
• Dedicated Training Resources and Learning & Development Programs
• Paid Educational Assistance
• US Only
• Center Valley, PA and Westborough, MA

Are you ready to be a part of our team?
Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks .
The anticipated base pay range for this full-time position is $144,541.00 - $216,812.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). This pay range represents the National Average of the range, and may vary depending on the location of the individual.
Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.
At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 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.
Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com .
You Belong at Olympus
We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.
Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact [e-mail]. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).
Let’s realize your potential, together.
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA)