Global Complaint Management Operations Director

Director, Global Complaint Management Operations

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 in Boston Scientific is working toward one goal - transforming lives by tackling some of the most important medical device industry challenges. Patient Care is at the center of everything we do and quality, compliance and patient outcomes are critical aspects of ensuring that we deliver on our commitment to Patient Care.

As the Director, Global Complaint Management Operations leading multiple teams across Interventional Cardiology, WATCHMAN, Electrophysiology, Cardiac Rhythm Management & Diagnostics, you will be responsible for developing, defining and executing a clear strategy for industry-leading post market complaint management. The strategy and associated execution are key to enabling PMQA to deliver increasing value to our patients, customers and company by supporting advancement of established divisional, global and BSC-level strategies and goals. This work integrates business and operational considerations and goals, anticipated opportunities and threats, and is in alignment with and enables success in meeting existing and evolving external Regulator requirements and expectations.

This role will report to VP, Global Quality Systems and Post Market Quality Assurance and will work in partnership with divisional Quality and cross-functional partners, regulatory and compliance leadership, PMQA functional leaders and other stakeholders, with accountability to achieve/support localized, divisional goals, while enabling, maintaining and evolving appropriate company-wide harmonization.

The Director will have strategic and operational accountability and oversight over key post market quality teams, activities and related infrastructure supporting the overall complaint handling process in accordance with relevant global regulations. Focus will be on 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.

This role is hybrid out of the Arden Hills office location requiring you to be onsite 3 days per week.

Your responsibilities include:

• Strategic and operational planning/execution
• People Management
• Complaint intake
• Complaint management
• Regulatory Reporting
• Collaborate with stakeholders
• Infrastructure & project management

Required Qualifications:

• Bachelor's degree required
• Minimum of 10 years of experience in Quality within Medical Device industry
• Minimum of 5 years in a leadership role; demonstrated success in project/program and people leadership domains
• Experience working with applicable regulatory requirements including ISO 13485, MDD/MDR, FDA QSR, Health Canada, ANVISA, TGA, NMPA and other international requirements as applicable
• Experience in dealing with external regulatory bodies and post market surveillance regulations
• Experience in working with third party vendors

Preferred Qualifications:

• Advanced degree preferred
• Demonstrated capability in collaborating and influencing across a global, matrixed organization
• Experience managing large-scale, complex programs/projects, business systems and information technology within Quality/compliance domain highly preferred
• Ability to make consequential decisions in a high-pressure environment, whilst bringing along stakeholders
• Demonstrated high degree of integrity, professionalism, and the ability to establish credibility internally and externally
• Promotes a high-performance, diverse and inclusive culture within a quality focused environment
• Demonstrated commitment to advancing BSC people leadership commitment through focus on coaching, listening, and developing team members
• High sense of urgency and commitment to execution
• Demonstrated problem-solving capabilities
• Strong business and financial acumen, with ability to quickly establish impact & consequences