Insulet Corporation · 7 hours ago
Director, IT – QMS and R&D Systems (Remote)
United States
Full-time
Remote
Director/Executive
$173K/yr - $259K/yr
10+ years expInsulet Corporation is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions. The Director of IT for Quality & Regulatory Systems will lead the strategic planning, implementation, and management of global systems that support Quality Assurance, Regulatory Affairs, and R&D Systems, ensuring alignment with business objectives and compliance with regulatory standards.
Health CareMedicalMedical Device
Responsibilities
Partner with business leaders to align IT strategies with R&D, Quality, Regulatory, and Post-Market priorities
Translate business needs into actionable technology roadmaps and solutions
Serve as a trusted advisor and provide thought leadership on emerging technologies, vendor capabilities, and industry trends
Oversee the lifecycle of validated systems including QMS platforms (e.g., TrackWise), Veeva systems, Polarion, eDHR, content management, and labeling tools
Lead planning, execution, and governance of programs and projects, ensuring timely delivery and compliance
Manage risk, scope, and change across initiatives to maintain alignment with business goals
Lead and mentor a global team of managers and professionals, fostering a culture of accountability, collaboration, and continuous improvement
Drive performance through coaching, feedback, and professional development
Promote cross-functional teamwork and knowledge sharing across IT and business units
Develop and manage KPIs, scorecards, and performance analytics to drive operational efficiency and continuous improvement
Ensure systems meet FDA, SOX, and other regulatory requirements, maintaining validated states and audit readiness
Champion best practices in system design, governance, and delivery methodologies (Agile, Scrum, Kanban, Waterfall)
Build trust-based relationships with business partners through active listening and strategic alignment
Manage vendor relationships, contracts, and third-party consultants to ensure quality and value
Support IT intake processes and collaborate with Enterprise Architecture, Procurement, and Agile Delivery Office
Work with global process owners to develop scalable, region-specific solutions
Evaluate third-party tools for feasibility and business impact
Contribute to product roadmaps and support geographic expansion strategies
Manage OPEX and CAPEX budgets for the team and assigned projects
Contribute to long-range planning and resource forecasting at the program level
Qualification
Required
Bachelor's degree in Computer Science, Information Systems, or related field
10+ years of IT experience, with 5+ years in leadership roles supporting regulated environments
3+ years of experience managing a team of senior managers or managers
Proven expertise in Quality, Regulatory and R&D systems within the medical device or any other regulatory controlled industry
Strong understanding of GxP, validation, and compliance frameworks
Exceptional communication, leadership, and stakeholder management skills
Experience with Agile and Waterfall methodologies, and global team management
Proven knowledge of the software and systems development life cycle
Preferred
Master's degree in Computer Science, Information Systems, or related field
International experience is strongly desired
Knowledge of BI or AI platforms is a plus
Experience in the healthcare, pharma or medical device industry a plus
Benefits
Medical, dental, and vision insurance
401(k) with company match
Paid time off (PTO)
And additional employee wellness programs
Company
Insulet Corporation
Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform.
1001-5000 employees
H1B Sponsorship
Insulet Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (58)
2024 (43)
2023 (19)
2022 (33)
2021 (41)
2020 (17)
Funding
Current Stage
Public CompanyTotal Funding
$629.5MKey Investors
DeerfieldOrbiMedAlta Partners
2025-03-18Post Ipo Debt· $450M
2009-03-16Post Ipo Debt· $60M
2007-05-15IPO
Leadership Team
Ashley McEvoy
President & Chief Executive Officer
Ana Maria Chadwick
Chief Financial Officer
Recent News
2025-12-20
2025-12-17
Company data provided by crunchbase