Boston Scientific · 5 hours ago
Product Complaint Associate Manager
Arden Hills, MN
Full-time
Hybrid
Mid, Senior Level
$72K/yr - $136K/yr
5+ years expBoston Scientific is a leader in medical science, committed to solving important health industry challenges. The Product Complaint Associate Manager will manage the Post Market Surveillance staff and oversee compliance activities related to complaint handling, ensuring alignment with corporate and global regulatory requirements.
Health CareMedicalMedical Device
No H1B
Responsibilities
Escalate and participate in resolution of potential product deficiencies for all applicable BSC products
Ensure site operational procedures support the corporate policies and guidance while also being aligned with all of the necessary regulations and standards
Consistent, positive influence on the culture of the team, setting an example as a leader of high-quality work, effective communication, dealing with adversity, and solution-oriented thinking
Manages performance and professional growth and development of staff
Monitors daily work operations to achieve company, division and project goals by providing direction and guidance to staff and empowering them to do their best work
Maintain processes and procedures for ensuring compliance to corporate policies as well as external regulations and standards
Understanding and ensuring compliance to US & OUS regulatory requirements for medical devices for complaint handling and regulatory reporting
Participating in the Global Quality Community to improve post market quality across multiple divisions
Coordinating parallel tasks and meetings to drive collaboration of multi-site and multi-functional stakeholders to support project deliverables and timelines
Provide clear communication on deliverables, timelines and milestones
Influence change and align stakeholders to make decisions with limited information
Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures
Coordinates and participates in escalation of adverse complaint trends or product issues
Ensure appropriate training is provided to the Post Market Surveillance staff
Recommend staffing or other necessary resources in order to achieve business goals and compliance requirements
Oversee the accuracy, completeness, and maintenance of the complaint records as it is documented in Global Complaint Management Database
Stay updated of the internal and external indicators by reviewing reports and newsletters, reading organizational literature, meeting with peers and reading departmental reports
Qualification
Required
Minimum bachelor's degree in a related field
Minimum of 5 years of medical device industry, pharmaceutical, or diagnostic device experience
Proven people leadership experience of minimum 3 years in a similar capacity – 4 or direct reports
Demonstrated experience or collaborating and communicating with regulatory bodies
Proven ability to manage shifting priorities in a dynamic environment
Preferred
Boston Scientific experience is preferred
Preferred experience with operational excellence – process optimization, problem solving, Six Sigma, lean methodologies
Proven experience working with competent authorities and notified bodies – FDA, BfArM, HPRA, etc
Proven experience with Interventional Cardiology and Vascular Therapy products
Preferred experience with Post Market activities – complaints, vigilance, CAPA
Proven experience supporting internal or external audits
Proven vendor management experience – oversight and execution of post -market process
Benefits
Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
Company
Boston Scientific
Boston Scientific is a medical technology company that designs and develops medical devices to diagnose and treat a wide range of condition.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$10.02B2025-02-21Post Ipo Debt· $1.58B
2024-02-22Post Ipo Debt· $2.17B
2022-03-04Post Ipo Debt· $3.28B
Leadership Team
Michael Mahoney
Chairman, President & CEO
Daniel J. Brennan
Chief Financial Officer
Recent News
2026-01-24
2026-01-23
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