Global Post-Market Quality Systems Leader

Boston Scientific; Marlborough (MA); Hybrid; USD 126,000 - 239,000; Full time

Job summary

Boston Scientific is seeking a Senior Manager, Global Post Market Quality Systems to define and execute a strategy for post-market quality. The role requires leading a team, aligning with global regulatory expectations and driving continuous improvement across the post-market landscape.

The position emphasizes collaboration with divisional quality teams, regulatory affairs, and cross-functional partners to advance enterprise-level goals while navigating evolving international requirements.

Qualifications

• Bachelor’s degree is required.
• 7+ years in the medical device industry.
• 3+ years in a leadership role, with demonstrated success in project/program leadership and people leadership.
• 3+ years in post-market quality or design assurance.
• Experience with ISO 13485, MDD/MDR, FDA QMSR, Health Canada, ANVISA, TGA, NMPA and other international requirements.
• Experience working with external regulatory bodies and post-market surveillance regulations.

Responsibilities

• Develop and execute a strategic vision and multiyear roadmap for post-market quality systems, including data analytics and AI capabilities.
• Collaborate with stakeholders to identify long-term objectives and close gaps with best practices.
• Serve as SME on global post-market quality regulations and regulatory expectations.
• Monitor regulatory trends and recommend process improvements.
• Lead and develop a high-performing team with a culture of collaboration and improvement.
• Manage team performance, resources and deliverables to meet objectives.
• Partner with global quality leaders to harmonize processes and drive efficiency.
• Influence strategy with data-driven recommendations.

Skills

Leadership

Data analytics

Regulatory knowledge

Education

Bachelor’s degree

Job description

Boston Scientific is seeking a Senior Manager, Global Post Market Quality Systems to define and execute a strategy for post-market quality. The role requires leading a team, aligning with global regulatory expectations and driving continuous improvement across the post-market landscape.

The position emphasizes collaboration with divisional quality teams, regulatory affairs, and cross-functional partners to advance enterprise-level goals while navigating evolving international requirements.