Senior Manager, Global Post Market Quality Systems

Senior Manager, Global Post Market Quality Systems

At Boston Scientific, we'll give you the opportunity to harness all that's 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, we'll help you in advancing your skills and career. Here, you'll be supported in progressing whatever your ambitions.

Everyone at Boston Scientific is working toward one goal: transforming lives by tackling some of the most important challenges in the medical device industry. Patient care is at the center of everything we do, and quality, compliance and patient outcomes are critical to delivering on that commitment.

As the Senior Manager, Global Post Market Quality Systems, you will be responsible for developing, defining and executing a clear strategy for industry-leading post-market complaint management. You will serve as a subject matter expert in post-market quality and help shape the future of post-market systems while influencing risk management strategies to ensure a comprehensive understanding of product performance.

The strategy and execution of this work are critical to enabling the post-market organization to deliver increasing value to patients, customers and the company by advancing divisional, global and enterprise-level strategies and goals. This role integrates business and operational priorities, anticipates opportunities and risks, and ensures alignment with evolving global regulatory requirements and expectations.

Reporting to the Director, Global Post Market Quality, you will partner closely with divisional quality teams, regulatory affairs, cross-functional stakeholders and global post-market quality leaders to drive consistency, compliance and continuous improvement across the organization.

This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

Your responsibilities will include:

• Develop and execute a strategic vision and multiyear roadmap for post-market quality systems, including the integration of data analytics and artificial intelligence capabilities.
• Collaborate with key stakeholders to identify long-term objectives, assess current-state gaps and implement industry best practices.
• Serve as a subject matter expert on global post-market quality regulations, requirements and regulatory expectations, ensuring organizational readiness and compliance.
• Monitor emerging regulatory trends and proactively recommend improvements to processes, systems and governance structures.
• Lead, coach and develop a high-performing team while fostering a culture of collaboration, accountability and continuous improvement.
• Effectively manage team performance, resource planning and deliverables to ensure achievement of strategic and operational objectives.
• Partner with global post-market quality leaders and cross-functional stakeholders to drive consistency, compliance and efficiency through harmonized processes and shared best practices.
• Influence organizational strategy and decision-making through strong stakeholder engagement and data-driven recommendations.

Required qualifications:

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

Preferred qualifications:

• Demonstrated ability to collaborate and influence across a global, matrixed organization.
• Experience managing large-scale, complex programs, projects, business systems and information technology initiatives within the quality and compliance domain.
• Ability to make consequential decisions in a fast-paced, high-pressure environment while effectively engaging stakeholders.
• Demonstrated integrity, professionalism and the ability to establish credibility with internal and external stakeholders.
• Experience fostering a high-performance, diverse and inclusive culture within a quality-focused environment.
• Demonstrated commitment to coaching, listening to and developing team members.
• High sense of urgency and strong commitment to execution.
• Strong problem-solving and critical-thinking skills.
• Experience with data analytics and artificial intelligence technologies preferred.