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Director Post Market Surveillance Jobs (NOW HIRING)

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Director - Post Market Quality

Austin, TX

EU MDR Post-Market Surveillance * Own the Post-Market Surveillance (PMS) system under EU MDR ... Direct Post-Market Clinical Follow-up planning and evaluation with Clinical and Regulatory Affairs ...

Merit

Senior Manager, Post Market Surveillance

Prepares for, participates in and assists with FDA facility inspections, Notified Body Audits, Post Market Surveillance activities and other governmental inspections as directed. * Drives continuous ...

Hologic, Inc.

NY · On-site

$170.70 - $303.60/hr

The Director of Post Market Compliance, Corporate plays a critical role in ensuring that the ... This role leads corporate oversight of complaint handling, post market surveillance, medical device ...

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Director Post Market Surveillance information

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$34K

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How much do director post market surveillance jobs pay per year?

As of Aug 21, 2026, the average yearly pay for director post market surveillance in the United States is $104,448.00, according to ZipRecruiter salary data. Most workers in this role earn between $71,500.00 and $131,500.00 per year, depending on experience, location, and employer.

What is a director post market surveillance?

A Director of Post Market Surveillance is a senior professional responsible for overseeing the monitoring and analysis of products after they have been released to the market, particularly in regulated industries like medical devices or pharmaceuticals. This role ensures that any issues, adverse events, or customer feedback are thoroughly investigated to maintain product safety and regulatory compliance. The director leads a team that collects data, identifies trends, and implements corrective actions when necessary. Their work is crucial for protecting public health, meeting regulatory requirements, and improving product quality.

What are the main challenges a director post market surveillance faces when ensuring product compliance across global markets?

A Director of Post Market Surveillance often navigates complex regulatory requirements that vary significantly between regions, such as the FDA in the U.S. and MDR in the EU. Coordinating timely data collection, adverse event reporting, and risk assessments across international teams can be demanding, especially when responding to emerging safety signals. Effective collaboration with regulatory affairs, quality, and engineering departments is crucial to ensure swift corrective actions and maintain compliance. Staying ahead of regulatory changes and fostering a culture of continuous improvement are key to success in this role.

What are the key skills and qualifications needed to thrive as a director post market surveillance, and why are they important?

To thrive as a Director of Post Market Surveillance, you need expertise in regulatory compliance, data analysis, risk management, and a background in life sciences or engineering, often supported by an advanced degree. Familiarity with quality management systems (like ISO 13485), adverse event reporting tools, and regulatory databases such as FDA’s MAUDE is essential. Strong leadership, communication, and problem-solving skills help drive cross-functional teams and manage complex safety issues. These skills ensure timely identification and mitigation of product risks, regulatory compliance, and protection of patient safety.

What is the difference between Director Post Market Surveillance vs Product Quality Manager?

AspectDirector Post Market SurveillanceProduct Quality Manager
CredentialsTypically requires advanced degrees in life sciences or engineering, plus experience in regulatory complianceUsually holds a degree in quality assurance, engineering, or related fields, with certifications like CQE or ISO auditor
Work EnvironmentWorks within regulatory, R&D, and compliance teams, often in medical device or pharmaceutical industriesOperates mainly in quality assurance departments, focusing on product standards and process improvements
Industry UsageCommonly found in medical device, pharmaceutical, and biotech sectorsWidely used across manufacturing, medical devices, and consumer products industries

The Director Post Market Surveillance focuses on monitoring product safety and compliance after market release, while the Product Quality Manager concentrates on maintaining product quality during manufacturing. Both roles require regulatory knowledge and quality assurance expertise but differ in scope and strategic focus.

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Director Post Market Surveillance jobs near you
Infographic showing various Director Post Market Surveillance job openings in the United States as of August 2026, with employment types broken down into 50% Full Time, and 50% Contract. Highlights an 100% In-person job distribution, with an average salary of $104,448 per year, or $50.2 per hour.

Senior Director, Post Market Monitoring

Olympus Corporation of the Americas

Westborough, MA • Remote

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 4 days ago

Olympus Corporation Of The Americas rating

8.2

Company rating: 8.2 out of 10

Based on 19 frontline employees who took The Breakroom Quiz

130th of 493 rated machine equipment manufacturers

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 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.
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, Cafe, 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 OCAAccommodations@olympus.com. 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) 

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