Product Complaint Manager

Boston Scientific•Santa Clarita, CA

3d•$103,700 - $197,000

About The Position

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 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. About the role: Responsible for managing the Post Market Surveillance staff and all related compliance activities associated with the complaint handling program at BSC per corporate, domestic and international standards. The scope of responsibility encompasses managing the complaint processes to comply with corporate/divisional procedures and FDA regulations per CFR Part 820 and 803, and International Regulations as applicable per geographies. 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. Serves as the Quality liaison between individuals and business units within or outside the organization regarding matters related to post market surveillance activities, including risk management and complaint handling processes for all applicable products.

Requirements

Bachelor's Degree
Minimum of 7+ years of medical device industry experience
Demonstrated ability to understand, shift and contribute to changing priorities

Nice To Haves

Boston Scientific experience
Knowledge of US and international regulatory authority reporting requirements
Experience working with Competent Authorities
Strong management and communication skills
Project management experience
Effective team leadership experience
Experience with Neuromodulation products
Experience with Post Market activities
Vendor management experience

Responsibilities

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 the staff through the PDC program and per BSC HR policies
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 lead large, highly impactful projects 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
Providing and presenting succinct, clear communication to senior leadership 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
Recommends staffing or other necessary resources in order to achieve business goals and compliance requirements
Oversees the accuracy, completeness, and maintenance of the complaint records as it is documented in Global Complaint Management Database
Monitors internal and external indicators by reviewing reports and newsletters, reading organizational literature, meeting with peers and reading departmental reports