Senior Manager, Global Post Market Quality Systems

Senior Manager, Global Post Market Quality Systems Additional Location(s): US-MN-Arden Hills; US-MA-Marlborough Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance 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. Responsibilities 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. Qualifications 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. 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. About the Work Model and Logistics 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. EEO Statement Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. Additional Requirements Workforce Health & Safety: This role is deemed safety‑sensitive. Applicants will be subject to a prohibited substance test as a requirement. Certain U.S. based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID‑19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. #J-18808-Ljbffr