Product Complaint Manager
About The Position
At Boston Scientific, we are dedicated to transforming lives by addressing critical challenges in the medical device industry. Patient care is central to our mission, and ensuring quality, compliance, and positive patient outcomes is paramount. Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list. As a Product Complaint Manager, you will lead complaint handling and post-market surveillance activities within the Electrophysiology Complaint Management Center (EP CMC). You will partner with the EP CMC leadership team and cross-functional partners to ensure a compliant and high-performing complaint handling program that supports patient safety and product quality. This role is crucial for driving operational excellence, overseeing the assessment and escalation of product issues, and supporting risk management activities to ensure patient safety and regulatory compliance. You will also be key in advancing continuous improvement, maintaining audit and inspection readiness, and ensuring alignment with evolving regulatory requirements.
Requirements
- Bachelor’s degree in a scientific, engineering, or technical discipline.
- Minimum of 7 years' experience in the medical device industry.
- Minimum of 3 years' experience in a leadership role within the medical device industry.
Nice To Haves
- Demonstrated leadership skills, including team development, performance management, and effective communication.
- Knowledge of U.S. and international regulatory reporting requirements, including FDA and global vigilance requirements.
- Experience supporting post-market quality activities, including complaint handling and vigilance.
- Experience interacting with regulatory authorities or Competent Authorities.
- Experience supporting audits or inspections, including front-room and back-room activities.
- Project management experience with the ability to drive initiatives to completion.
- Experience managing external partners or vendors.
Responsibilities
- Lead and develop a high-performing team responsible for daily complaint handling operations, providing direction to supervisors and staff while driving performance, engagement, and team development.
- Assess resource needs, support hiring and onboarding activities, and build organizational capability through training and professional development.
- Ensure complaints are reviewed, investigated, and documented in accordance with corporate policies and global regulatory requirements, including FDA and international regulatory authorities.
- Maintain accurate, complete, and compliant complaint records within the Global Complaint Management Database.
- Identify and implement process, system, and workflow improvements to enhance efficiency, quality, and compliance.
- Oversee third-party and off-site teams to ensure adherence to quality and regulatory standards.
- Lead structured problem-solving activities and manage escalation of adverse trends, product issues, and operational risks.
- Support internal and external audits and inspections and maintain ongoing team readiness through training and compliance activities.
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- Life insurance
- Disability insurance
- 401k
- Employee stock purchase plan
- Professional development
- Learning and development program
- Wellness programs
- Employee discount programs
- Relocation assistance is not available for this position at this time.
- Sponsorship or take over sponsorship of an employment visa is not offered at this time.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
