Senior Product Complaint Manager

Additional Location(s): US-MN-Arden Hills; Ireland-Galway; US-MN-Maple Grove

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

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.

 

About the role:

The Senior Product Complaint Manager will be responsible for planning, developing, and maintaining Post Market Surveillance compliance programs for the Cardiovascular Complaint Management Center supporting the Interventional Cardiology division. He/she will have operational accountability over understanding, documenting and communicating device performance through timely capture of field performance inputs, comprehensive investigation and analysis of relevant supporting data, consistent assessment of reporting obligations across all teams in accordance with evolving worldwide regulations, and effective, timely correspondence with customers and worldwide regulatory agencies.  A key aspect of this role includes strong partnership with divisional and global Quality/Regulatory and other stakeholders to communicate overall product performance aligned with clinical and risk management product profiles.  He/she/they will work closely with CMC Managers to establish and ensure compliance with applicable global regulations (e.g. FDA 21 CFR Part 820.198, FDA 21 CFR Part 803, EU MDR, ISO 13485:2016), company and department policies and procedures.

 

Your responsibilities will include:

• Collaborate with divisional partners and enable PMQA to be an optimally effective partner in achieving goals and delivering products of the highest quality.
• Work closely with and collaborate with Post Market QA peers/leaders to ensure BSC-wide consistency, compliance and efficiency through shared best practices and thoughtful harmonization
• Determine appropriate staff levels, schedules and resources.
• Recruit, coach and develop organizational talent to create a culture of effective influence and collaboration for results.
• Provide oversight to work done offsite and by 3rd party vendors to ensure adherence to standards.
• Provide education on complaint reporting requirements to worldwide BSC employees
• Develop and implement department tools and methodologies pertaining to the product complaint management process to ensure compliance and to drive continuous improvement.
• Develop and maintain Post Market Compliance programs, policies, and processes.
• Develop and facilitate training and training support for the Post Market Surveillance organization.
• Partner with quality writing board and risk management teams to ensure written communications are complete and align with overall product risk profile.
• Act as an effective and collaborative leader or team member in supporting quality disciplines, decisions, and practices.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Drive projects of major magnitude and scope.
• Support development and execution of streamlined business systems which effectively identify and resolve quality issues.
• Provide solutions to a variety of technical and systematic problems of moderate to major scope and complexity.

 

Required Qualifications:

• Minimum of a Bachelor’s Degree
• Minimum of 10 years of related experience (complaint management, post market surveillance, quality systems)
• Minimum of 3 years of management experience
• Medical device experience