Global Complaint Management Operations Director

Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance At Boston Scientific, we give you the opportunity to harness all that’s within you by working with 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 help you advance your skills and career. Here you are supported in progressing – whatever your ambitions. Director, Global Complaint Management Operations About the role: Everyone at 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 – quality, compliance and patient outcomes are critical to delivering on our commitment to patient care. As the Director of Global Complaint Management Operations, leading multiple teams across Interventional Cardiology, WATCHMAN, Electrophysiology, Cardiac Rhythm Management & Diagnostics, you will develop, define and execute a clear strategy for industry‑leading post‑market complaint management. The strategy and associated execution support PMQA in delivering increasing value to patients, customers and the company by supporting the division’s, global and BSC‑level strategies and goals. You will integrate business and operational considerations, identify opportunities and threats, and ensure alignment with evolving external regulator requirements and expectations. This role reports to the VP, Global Quality Systems and Post‑Market Quality Assurance and works in partnership with divisional quality, cross‑functional partners, regulatory and compliance leadership, PMQA functional leaders and other stakeholders. You will achieve and support localized and divisional goals while enabling, maintaining and evolving company‑wide harmonization. The Director has 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 is on understanding, documenting and communicating device performance through timely capture of field performance inputs, comprehensive investigation and analysis of supporting data, consistent assessment of reporting obligations across teams and effective correspondence with customers and worldwide regulatory agencies. A key aspect is 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 onsite work 3 days per week. Your responsibilities include: Strategic and operational planning/execution : Develop a cascading/supporting strategy and strategic initiatives reflective of an industry‑leading Post Market QA function enabling BSC, Global Quality, Post Market QA and the Division to achieve specific goals in alignment with patient‑centric quality. Demonstrate successful execution and continuous improvement via achievement of KPIs and specific measures. People Management : Effectively lead the team in planning and managing tasks and achieving deliverables according to established plans and goals; manage performance and encourage/support development of team members. Ensure overall functional excellence within the team and foster a culture of effective influence and collaboration for results. Complaint intake : Optimize the process and tools to capture feedback, provide education on complaint reporting requirements to worldwide BSC employees, and collaborate with the commercial organization to maximize value and adoption/compliance. Complaint management : Oversee global complaint management process, practices and outcomes, documenting, assessing and communicating performance feedback on market approved BSC product portfolio in accordance with external regulations. End‑to‑end communication, both internally within BSC and to external customers and regulators, must be clear, accurate and consistent. Regulatory Reporting : Ensure consistent compliance to worldwide vigilance reporting regulations across all divisions and products. Partner with quality writing board and risk management teams to ensure written communications are complete and align with overall product risk profile. Collaborate with stakeholders : Partner with QA/RA and relevant BSC teams and leadership on projects/programs and infrastructure work as needed and appropriate to assure mutual success. Collaboration with divisional partners enables Post Market QA to be an optimally effective partner in achieving goals and delivering products of the highest quality. Work closely with Post Market QA peers/leaders to ensure BSC‑wide consistency, compliance and efficiency through shared best practices and thoughtful harmonization. Infrastructure & project management : Identify and lead projects and programs in concert with broader Post Market QA partners and other teams as applicable to ensure the team has infrastructure and tools needed to achieve strategic initiatives and established goals. Work with partners to identify gaps and plan/execute on resolutions both locally and as part of a cohesive BSC‑wide Post Market QA team. Required Qualifications: Bachelor’s degree required Minimum of 10 years of experience in quality within the 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 – ISO 13485, MDD/MDR, FDA QSR, Health Canada, ANVISA, TGA, NMPA and other international requirements as applicable Experience dealing with external regulatory bodies and post‑market surveillance regulations Experience 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 while bringing along stakeholders Demonstrated high degree of integrity, professionalism, and 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 Requisition ID: 629663 Minimum Salary: $155,000 Maximum Salary: $294,500 The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see bscbenefitsconnect.com – will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above. Compensation for non‑exempt (hourly), non‑sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements). Compensation for exempt, non‑sales roles may also include variable compensation, i.e., annual bonus target and long‑term incentives (subject to plan eligibility and other requirements). For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability. Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high‑performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at and follow us on LinkedIn . Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. Please be advised that certain U.S. based positions, including field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID‑19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID‑19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID‑19 vaccination. Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety‑sensitive positions. This role is deemed safety‑sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law. #J-18808-Ljbffr Boston Scientific