Job was saved successfully.
Job was removed from Saved Jobs.

Job Details

Bristol Myers Squibb

Director Device Post-Market Surveillance (PMS)


Medical Director


Devens, Massachusetts, United States

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

The Director of Device Post-Market Surveillance is responsible for the maintenance and continuous improvement of the BMS post-market surveillance process for devices and combination products. In this capacity, the Director will act as the Global Process Owner (GPO) for post-market surveillance and support an end-to-end global process spanning new product development and lifecycle management.

This position will be highly visible with key collaborative relationships across functions and global locations including manufacturing sites and in-market reporting partners. The role will be an individual contributor with the potential to expand and grow with both direct and in-direct staff that execute operational activities within post-market surveillance including: Specifically, the incumbent will work cross-functionally with a team to develop a process and system that contains at minimum the following elements: (1) creation of the post-market surveillance plan for new pipeline assets, (2) defining roles and responsibilities in the execution of the post-market surveillance plan throughout the clinical/commercial lifecycle, (3) periodic reporting against planned activities and (4) adverse event and complaint monitoring inclusive of regulatory reporting ensuring close connectivity to the world wide patient safety organization and our manufacturing sites.


  • Global Process Owner (GPO) for Device Post-Market Surveillance
  • Own and maintain all procedures and processes related to planning, reporting and monitoring of lifecycle devices and combination products.
  • Collaborate with the Head of Device and Combination Products QMS in the identification of electronic tools and systems for PMS.
  • Own the tracking, trending and regulatory reporting of global adverse events for medical devices and combination products. Ensure timeliness and accuracy of regulatory reporting.
  • Participate in Quality Councils (Level I-III) representing product lifecycle metrics, trends and issue escalation.
  • Ensure all new product development assets have post-market surveillance plans prior to commercial launch and establish the reactive and proactive leading indicators that form the foundation for lifecycle monitoring.
  • Execute post-market surveillance plans in the commercial lifecycle including periodic review and reporting requirements.
  • Maintain stewardship for the quality history of commercial device and combination product assets throughout the product lifecycle.
  • Serve as an SME related to Post-Market Surveillance, Device Risk Management and Adverse Event Reporting.
  • As needed, participate on teams to ensure robust application of appropriate controls in the design, development, qualification, commercialization and lifecycle management of pipeline and portfolio products.
  • Engages in continuous improvement activities by identifying opportunities and recommending improvements to design and development process.
  • Continuously develop and provide mobility for leaders within BMS while ensuring a robust pipeline of talent and succession planning.
  • Actively participate in industry associations, conferences and forums, remaining current on emerging technologies, market trends and changing regulations/standards.


B.A. / B.S. and 10+ years of experience in industry or combined industry and research

M.A. / M.S. and 8+ years of experience in industry or combined industry and research


  • Subject matter expert in the areas of Device and Combination product lifecycle management, risk management and post-market monitoring
  • Deep understanding of the Reactive and Proactive indicators utilized to monitor and confirm performance of devices within the lifecycle (including tools and techniques for assessment)
  • Knowledge of drug substance, drug product and primary containers is preferred
  • Exposure to a diverse technology landscape including delivery systems, companion diagnostics, digital applications and durable devices
  • Skilled oral and written communicator with an ability to identify problems, review related information, develop and evaluate options, and implement solutions
  • Experience working in a matrixed organization, leading through influence across stakeholders (Research & Early Development, Product Development, Commercial and Manufacturing Science & Technology)
  • Expert knowledge of device and combination product regulations/standards including 21 CFR Part 820, Part 3, Part 4, ISO13485, ISO14971, MDR2021 and IVDR2022
  • Awareness of pharmaceutical and biologic regulations and standards including 21 CFR Part 210, 21 CFR part 600, 2010/83/EC and relevant ICH guidelines
  • Knowledge of continuous improvement methodologies and practices including Lean and Six Sigma
  • Prior experience with regulators including back and front room inspection experience
  • Expert knowledge of global device and combination product adverse event reporting requirements (MDR, MDV, etc..)
  • Experience with the monitoring and analysis of post-market data including reactive and proactive data sets
  • Experience with establishing and maintaining a relationship with Notified Bodies in the EU for both CE mark certification and MDR opinions
  • Demonstrated ability to collaborate and influence in a matrix environment with good oral and written communication skills
  • System-based thinking with ability to develop and implement new systems and continuously improve them
  • Ability to travel up to 20% globally

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to Visit to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.