Boston Scientific · 4 hours ago
Vice President, Global Quality - Post Market
Marlborough, MA
Full-time
Onsite
Director/Executive
$226K/yr - $429K/yr
15+ years expBoston Scientific is a global leader in the health industry, and they are seeking a Vice President, Global Quality – Post Market to define and execute their vision for post-market quality excellence. This role involves strategic leadership in complaint management and regulatory compliance, ensuring that the company meets and exceeds global regulatory expectations while safeguarding patient safety.
Health CareMedicalMedical Device
Responsibilities
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
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
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
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
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
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
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
Qualification
Required
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
Proficiency in English essential for effective communication and alignment
Knowledge of French (oral and written) required in Québec
Preferred
Advanced degree preferred
Significant leadership experience in medical device Post-Market Quality, complaint handling, or vigilance
Experience leading global transformation initiatives in Quality Systems
Company
Boston Scientific
Boston Scientific is a medical technology company that designs and develops medical devices to diagnose and treat a wide range of condition.
10001+ employees
H1B Sponsorship
Boston Scientific 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 (114)
2024 (106)
2023 (93)
2022 (140)
2021 (111)
2020 (97)
Funding
Current Stage
Public CompanyTotal Funding
$10.02B2025-02-21Post Ipo Debt· $1.58B
2024-02-22Post Ipo Debt· $2.17B
2022-03-04Post Ipo Debt· $3.28B
Leadership Team
Michael Mahoney
Chairman, President & CEO
Daniel J. Brennan
Chief Financial Officer
Recent News
2026-01-22
Company data provided by crunchbase