Global Complaint Management Operations Director

Additional Location(s): US-MN-Maple Grove; US-MA-Marlborough

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:
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. 

The Global Complaint Management Operations Director will lead multiple teams across Interventional Cardiology, WATCHMAN, Electrophysiology, Cardiac Rhythm Management & Diagnostics. This role 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.

The Global Complaint Management Operations Director will report to VP, Global Quality Systems and Post Market Quality Assurance and 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 Global Complaint Management Operations 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.  The 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. 
 
 

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/specific measures and demonstration of value provided. Goals are expansive and inclusive of compliance, financial, operational and business considerations, and include support and preparedness for new products and acquisitions.
• People management: Effectively lead the team in planning and managing tasks and achieving deliverables according to established plans and goals; effectively manage performance and encourage/support development of team members. Ensure overall functional excellence within team and foster a culture of effective influence and collaboration for results.
• Complaint intake:  Ensure process and tools to capture feedback are optimized to collect comprehensive information; provide education on complaint reporting requirements to worldwide BSC employees.  Requires strong collaboration with commercial organization to maximize value and adoption/compliance.
• Complaint management: Oversee global complaint management process, practices and outcomes, with a key goal of documenting, assessing and communicating performance feedback on market approved BSC product portfolio in accordance with external regulations.  Priority is to ensure patient safety and draw conclusions that enable product improvements.  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 in 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 and collaborate 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 own/lead projects and programs, in concert with broader Post Market QA partners and other teams as applicable, to ensure team has infrastructure and tools needed to be successful in delivery of strategic initiatives and established goals. Work with partners to identify gaps and plan/execute on resolutions, both locally and part of a cohesive BSC-wide Post Market QA team.

Required Qualifications:

• Minimum of a Bachelor’s degree
• Minimum of 10 years of related experience in Quality 
• Minimum of 5 years of direct or indirect leadership experience with demonstrated success in project/program management
• Medical device experience 
• 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 
• Experience managing large-scale, complex programs/projects, business systems and information technology within Quality/compliance domain
• Experience working with acquisitions and due diligence efforts
• Demonstrated problem solving capabilities, high sense of urgency, and commitment to execution
• Strong business and financial acumen, with ability to quickly establish impact & consequences
• Demonstrated capability in collaborating and influencing across a global, matrixed organization
• 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
• Ability to promote 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
   

Requisition ID: 583958

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement.  The goal of the drug testing is to increase workplace safety in compliance with the applicable law.  

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

Please be advised that certain US based positions, including without limitation 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.