Product Complaint Associate Manager

Additional Location(s):  N/A

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 Product Complaint Associate Manager 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 Senior Manager, Product Complaint Manager.

Work Mode, visa sponsorship, and relocation:

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 or support 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 bachelor’s degree in a related field
• 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 direct reports
• Demonstrated experience or collaborating and communicating with regulatory bodies 
• 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
• Proven experience working with competent authorities and notified bodies – FDA, BfArM, HPRA, etc.
• Proven experience with Interventional Cardiology and Vascular Therapy 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

Requisition ID: 622370 

Minimum Salary: $ 71500 

Maximum Salary: $ 135800 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.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.

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 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 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.

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.