Product Complaint Manager

Product Complaint Manager

Work mode: Hybrid Onsite Location(s): Carlsbad, CA, US, 92011 Additional Location(s): US-CA-Valencia; US-MN-Arden Hills; US-MN-Maple Grove 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. About the role: Everyone at Boston Scientific works toward one goal: transforming lives by addressing the most critical challenges in the medical device industry. Patient care is at the heart of everything we do, and ensuring quality, compliance and positive outcomes is essential to delivering on that commitment. Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day. Responsible for leading the Post Market Surveillance team and managing all compliance activities associated with Boston Scientific's complaint handling program in accordance with corporate, domestic and international standards. This role oversees complaint handling processes to ensure compliance with corporate and divisional procedures, FDA regulations, including 21 CFR Parts 820 and 803, and applicable international regulations. The manager escalates and participates in the resolution of potential product deficiencies, ensures site operational procedures align with corporate policies and regulatory requirements, and serves as the quality liaison for post market surveillance activities, including risk management and complaint handling processes across applicable product portfolios. Work model, sponsorship, relocation: At Boston Scientific, we value collaboration and synergy. 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: Foster a positive, high-performing team culture by leading through example, promoting high-quality work, effective communication, resilience and solution-oriented thinking. Manage employee performance, professional development and career growth through the Performance and Development Conversation (PDC) process and Boston Scientific HR policies. Oversee daily work operations to achieve company, divisional and project objectives by providing direction, coaching and support while empowering employees to perform at their best. Maintain processes and procedures that ensure compliance with corporate policies, external regulations and applicable quality standards. Ensure compliance with U.S. and international medical device regulatory requirements related to complaint handling and regulatory reporting. Lead highly impactful cross-functional initiatives within the Global Quality Community to improve post market quality across multiple divisions. Coordinate multiple projects, priorities and stakeholder meetings across sites and functions to achieve project deliverables and timelines. Prepare and deliver clear, concise communications and project updates to senior leadership regarding deliverables, milestones and timelines. Influence change, build alignment and facilitate decision-making in situations involving ambiguity or limited information. Build effective relationships with internal and external stakeholders by responding to requests, providing guidance and explaining processes and procedures. Coordinate and participate in the escalation and resolution of adverse complaint trends and potential product issues. Ensure Post Market Surveillance employees receive appropriate onboarding, compliance and ongoing training. Assess staffing needs and recommend resources necessary to achieve business objectives and maintain regulatory compliance. Oversee the accuracy, completeness and maintenance of complaint records within the Global Complaint Management Database. Monitor internal and external quality indicators by reviewing reports, industry publications, regulatory updates and organizational communications to identify opportunities for continuous improvement. Qualifications: Required qualifications: Bachelor's degree. Minimum of 7 years' experience in the medical device industry. Demonstrated ability to adapt to changing priorities while contributing effectively in a dynamic environment. Preferred qualifications: Boston Scientific experience. Knowledge of U.S. and international regulatory reporting requirements. Experience working with competent authorities. Strong people leadership, communication and organizational skills. Project management experience. Demonstrated experience leading high-performing teams. Experience supporting Neuromodulation products. Experience with post market surveillance activities. Vendor management experience. Minimum Salary: $ 106800 Maximum Salary: $ 202900