Vice President, Global Quality - Post Market

bostonscientific•Maple Grove, MA

3d•$225,900 - $429,200

About The Position

The Vice President, Global Quality – Post Market, is a key enterprise leader responsible for defining and executing Boston Scientific’s global vision for complaint management, vigilance, and post-market quality excellence. This role provides strategic guidance, deep domain expertise, and executive leadership to ensure our global post-market systems meet and exceed regulatory expectations, safeguard patient safety, and provide timely, actionable insights that drive business decisions. The VP will oversee enterprise-wide complaint intake, evaluation, reporting processes, and product performance monitoring. They will ensure robust compliance with medical device and combination product regulations (U.S., EU MDR, and OUS markets) and serve as a primary interface with global regulatory agencies. This leader will influence corporate Quality, Regulatory Affairs, Clinical, Operations, and R&D to ensure fully integrated, future-ready post-market capabilities and will shape Boston Scientific’s perspective on evolving global regulatory landscapes. They will serve as a key member of the Quality System Governance Board and the senior QA leadership team, shaping long-term system strategy, governance, and prioritization through the QMP process.

Requirements

Bachelor’s degree required
Minimum 15 years of progressive leadership experience in Quality and/or Regulatory within medical devices and/or pharmaceuticals
Demonstrated success leading complex global, matrixed organizations and influencing diverse stakeholder groups
Proven experience interacting directly with global regulatory bodies
Strong track record developing and executing Quality strategies that translate into measurable operational and cultural improvements
Exceptional leadership, communication, and relationship-building skills with a strong customer and patient focus
High degree of integrity, sound judgment, and executive presence

Nice To Haves

Advanced degree preferred
Significant leadership experience in medical device Post-Market Quality, complaint handling, or vigilance
Experience leading global transformation initiatives in Quality Systems

Responsibilities

Strategic Leadership & Vision Develop and execute the enterprise strategic roadmap for Post-Market Quality Systems, ensuring alignment with corporate strategy, global regulatory trends, and business needs.
Provide thought leadership on emerging regulatory changes and proactively guide the organization through evolving expectations related to complaint handling, vigilance, and product performance.
Set and sustain a global organizational structure that is agile, high-performing, and capable of scaling with evolving business and regulatory demands.
Post-Market Quality System Excellence Oversee the global complaint management process, including intake, evaluation, escalation, and reporting, ensuring compliance and operational excellence across all divisions and geographies.
Drive the evolution of product performance monitoring processes, ensuring leading-practice tools, analytics, and methodologies.
Own enterprise post-market metrics and dashboards used by senior management to assess quality system health and product performance.
Organizational Leadership & Talent Development Build and mentor a high-performing global Post-Market Quality organization, fostering a culture of collaboration, accountability, and innovation.
Equip teams with modern tools, technologies, and processes to enhance efficiency and enable real-time quality insights.
Quality Governance & Cross-Functional Influence Serve as a key member of the Quality Management Board; lead governance activities that determine system coherence, compliance, and strategic focus.
Provide executive oversight for the development, harmonization, and continuous improvement of SOPs, policies, and quality management processes.
Influence decision-making and prioritization across functions, ensuring alignment of cross-functional efforts supporting Post-Market Quality Systems.
Regulatory Agency Engagement Act as a senior representative for interactions with FDA and global regulatory authorities.
Oversee complaint-related regulatory submissions, field actions, PIR communications, and agency responses.
Cultivate external partnerships with regulators, industry groups, and trade associations; influence policies and emerging regulations in ways that are balanced, science-based, and aligned with patient safety.
Audit & Compliance Leadership Coordinate global audit-readiness activities and ensure headquarters and site audit performance reflects a culture of excellence and transparency.
Maintain a strong compliance posture through proactive risk identification, issue escalation, and unified corrective action strategies.
Technology, Data, and Innovation Lead digital and technological advancements within Post-Market Quality (e.g., automation, AI/ML analytics, systems integration).
Manage budgets, resource allocation, and timelines for key initiatives to ensure value delivery and operational optimization.
Build a global organization that is efficient, effective and meets global strategic needs.