Product Complaint Associate Manager

Boston Scientific•Arden Hills, MN

22h•$71,500 - $135,800•Hybrid

About The Position

The Product Complaint Associate Manager is responsible for managing the Post Market Surveillance (PMS) staff and overseeing compliance activities associated with Boston Scientific’s complaint handling program, in alignment with corporate, domestic, and international regulations. This includes ensuring compliance with CFR Part 820 and 803, and other applicable global regulatory requirements. The Associate Manager serves as a quality liaison across business units, both internally and externally, with responsibility for risk management and complaint handling processes. This individual plays a critical role in driving patients’ safety and product quality, while demonstrating a consistent commitment to Boston Scientific’s Quality Policy and documented procedures. This position reports to the Senior Manager, Product Complaint Manager.

Requirements

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

Nice To Haves

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

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