Global Post-Market Quality Systems Leader

Boston Scientific; Arden Hills (MN); Hybrid; USD 126,000 - 239,000; Full time

Job summary

Boston Scientific seeks a Senior Manager, Global Post Market Quality Systems to define and execute a clear strategy for post-market quality. You will partner with global teams to drive risk management and compliance across the product lifecycle.

This role demands leadership, cross-functional influence and a data-driven approach to improve processes, enable value delivery to patients, and align with evolving regulatory requirements.

Qualifications

• Bachelor’s degree required.
• 7+ years in the medical device industry.
• 3+ years in leadership, project/program leadership and people leadership.
• Experience with ISO 13485, MDD/MDR, FDA QMSR, Health Canada, ANVISA, TGA, NMPA and other international requirements.

Responsibilities

• Develop and execute a strategic vision and multiyear roadmap for post-market quality systems, including data analytics and AI capabilities.
• Collaborate with key stakeholders to identify long-term objectives, assess gaps and implement best practices.
• Serve as SME on global post-market quality regulations and regulatory expectations, ensuring readiness and compliance.
• Monitor regulatory trends and recommend improvements to processes, systems and governance structures.
• Lead, coach and develop a high-performing team with a culture of collaboration and continuous improvement.
• Effectively manage team performance, resource planning and deliverables to meet objectives.
• Partner with global leaders to drive harmonized processes and shared best practices.
• Influence strategy through data-driven recommendations.

Skills

Leadership

Strategic thinking

Regulatory knowledge

Project management

Data analytics

Cross-functional collaboration

Education

Bachelor’s degree

Job description

Boston Scientific seeks a Senior Manager, Global Post Market Quality Systems to define and execute a clear strategy for post-market quality. You will partner with global teams to drive risk management and compliance across the product lifecycle.

This role demands leadership, cross-functional influence and a data-driven approach to improve processes, enable value delivery to patients, and align with evolving regulatory requirements.