Associate Product Complaint Manager

Associate Product Complaint Manager

This role 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 Manager, Product Complaint.

This role follows a hybrid work model requiring employees to be in our Arden Hills, MN 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.

This role will not provide relocation support or assistance.

Your responsibilities will include:

• 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

Required qualifications:

• 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 more employees
• Proven ability to manage shifting priorities in a dynamic environment

Preferred qualifications:

• Boston Scientific experience is preferred
• Preferred experience with Operational Excellence – process optimization, problem solving, Six Sigma, Lean methodologies
• Demonstrated experience or collaborating and communicating with regulatory bodies
• Proven experience working with competent authorities and notified bodies – FDA, BfArM, HPRA, etc.
• Proven experience with Electrophysiology 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