Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.

We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!

Position Overview:

This position is responsible for providing support in making strategic and tactical data-related decisions by analyzing, manipulating, tracking, internally managing, and reporting post-market surveillance data and leading and supporting post-market projects through a methodical approach of planning, executing, and tracking project deliverables from start to finish. The Sr. Post-Market Analyst works collaboratively with the Post-Market Surveillance and Compliance leadership team and other functions as needed to address key safety, quality, and compliance questions using the appropriate tools/skills to derive the best answers, to help drive required actions, and ensure project progress and success.The Sr. Post-Market Analyst will be expected to provide insight and recommendations based on analysis involving data, systems, and performance. This individual will identify opportunities for improvement within existing processes, partner on the development of reporting tools to support objectives, deliver analysis, and track performance and productivity. This individual will provide strategic and tactical support by analyzing, maintaining, and cleansing data from various sources, including TrackWise.  Additionally, the Sr. Post-Market Analyst may be asked to support post-market compliance by (a) assessing the need for new or revised procedures/instructions and/or corrections or corrective actions and (b) helping to drive these changes forward; and (c) leading or supporting non-routine and/or high-impact requests for additional information (RFAI) related to vigilance.

Responsibilities:

Optimize the process for collecting and analyzing data across multiple systems to provide scheduled and ad hoc analysis and reporting to stakeholders.Develop and maintain reports and dashboards.Extract data and perform detailed data analysis. Produce and deliver reports on a routine basis to support the company’s operational initiatives.Communicate the results of data analysis in written and verbal form to leadership.Support annual product review and generation of draft and finalized PSURs, CSRs, PMCF Evaluation Reports and other inputs/outputs of annual product review.Support patient safety review meetings through data generation, analysis, and action management.Responsible for planning and tracking project performance in relation to short- and long-term goals and keeping actions on schedule, covering data projects and other special projects for the department.Aid in the preparation and delivery of status updates to management and other stakeholders.Create meeting agenda, coordinate meetings, and drive meeting minutes and actions.Adhere to all regulatory agency standards, company quality standards, and corporate policies.Perform other duties as required.

Education and Experience:

Minimum Requirements:

Bachelor's Level Degree5+ years of demonstrated experience in post-market surveillance, quality assurance, regulatory compliance, data analysis/analytics or data reporting, and/or project management in the medical device and/or life sciences industry.Strong organizational skills.Ability to analyze problems and develop solutions.Ability to effectively communicate both internally and externally.Ability to foster teamwork to work cooperatively and effectively with team members and to influence without authority.  Positive, results driven, rational, logical, team player.Demonstrated flexibility and ability to function in a fast-paced, growth industry and work environment. Ability to accurately execute multiple tasks and prioritize effectively with high attention to detail and drive for getting results.Ability to work independently and on multiple projects against deadlines.Flexibility to move between routine operational and project tasks quickly and seamlessly.Working knowledge of MS Office products, Outlook, Word, Excel, and PowerPoint and project management software.Ability to understand medical/clinical and technical aspects of product.Knowledgeable of Medical Device Regulations.Perform other duties as required.

Preferred Skills and Competencies:

Advanced MS Excel skills.Familiarity with Spotfire, Trackwise.Excellent writing skills.Excellent influencing and negotiating skills.Ability to rapidly learn and take advantage of new concepts, business models, and technologies.Proficiency with Medical Device regulations, particularly as they relate to post-market surveillance, vigilance, complaint handling, and risk management.

Physical Requirements (if applicable):  

This position requires extensive computer use.This position may require travel (domestic and international): some travel to Insulet sites will be required on occasion.