Vice President, Global Quality Post Market

Additional Location(s):US-MN-Arden Hills; US-MN-Maple Grove

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance

At Boston Scientific well give you the opportunity to harness all thats within you by working in teams of diverse and high-performing employees tackling some of the most important health industry challenges. With access to the latest tools information and training well help you in advancing your skills and career. Here youll be supported in progressing whatever your ambitions.

About the role:

The Vice President Global Quality Post Market is a key enterprise leader responsible for defining and executing Boston Scientifics 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 Scientifics 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.

Your responsibilities will include:

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.

Required Qualifications:

• Bachelors 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

Preferred Qualifications:

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

Requisition ID:623118

Minimum Salary: $225900

Maximum Salary: $429200

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) see --will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training pertinent education including licensure and certifications among other relevant business or organizational needs. At BSC it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for hourly non-sales roles may also include variable compensation from time to time (e.g. any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for salaried non-sales roles may also include variable compensation i.e. annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

Compensation for sales roles is governed by Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives).

Our organization is across Canada and has commercial representation in 140 countries.

This job involves regular collaboration with colleagues clients and stakeholders across Canada the U.S. and/or internationally making proficiency in English essential for effective communication and alignment. English is necessary for engaging with a range of documentation and maintaining effective communication if interacting with external clients or vendors.

As detailed in the job description this job involves communicating both verbally and in writing with other Boston Scientific teams located across Canada the United States and/or with our international clients and partners. International customers and partners represent an important part of our activities. Based on an evaluation we have determined that the duties of Vice President Global Quality - Post Marketposition require knowledge of English in addition to French (oral and written). We also determined that the English language skills already required of other employees do not permit the performance of English language skills tasks related to Vice President Global Quality - Post Marketposition.

However in Québec Boston Scientific limits as much as possible the number of positions for which it requires the knowledge of another language than French. Boston Scientific solely requires proficiency in English where it is necessary for the performance of an employees duties.