Product Complaint Manager
Marlborough, MA, US, 01752
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:
Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day.
Responsible for leading Post Market Vigilance staff and overseeing all compliance activities related to the complaint handling program at Boston Scientific. This role ensures alignment with corporate, domestic and international regulatory requirements, including FDA regulations (21 CFR Parts 820 and 803) and applicable global standards. You will drive the effectiveness of complaint processes, support risk management activities and serve as a key quality liaison across functions to ensure product safety, regulatory compliance and continuous improvement.
Work model, sponsorship, relocation:
At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local 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. Relocation assistance is not available for this position at this time.
Your responsibilities will include:
- Ensure all complaints are reviewed, evaluated and investigated to determine reportability to the FDA and international regulatory authorities
- Monitor daily operations and provide direction to supervisors, exempt employees and nonexempt staff to achieve team and project goals
- Plan for the impact of new products, including training, implementation and control plans
- Maintain processes and procedures to ensure compliance with corporate policies and external regulations and standards
- Contribute to the development of operational policies and procedures impacting the assigned organizational unit
- Monitor compliance with company policies and applicable regulations, including FDA and international standards
- Initiate and implement corrective and preventive actions in accordance with established procedures
- Partner with internal and external stakeholders by responding to requests, leading discussions and explaining processes
- Interact with internal, domestic and international auditors during audits and inspections
- Coordinate and support escalation of adverse complaint trends and product issues
- Ensure appropriate training is provided to Post Market Surveillance staff
- Manage performance, professional development and growth of team members
- Assess and address ongoing skill and development needs to ensure team capability
- Recommend staffing and resource needs to meet business and compliance objectives
- Oversee the accuracy, completeness and maintenance of complaint records in the global complaint management database
- Monitor internal and external indicators through reports, publications and cross-functional engagement
- Contribute to budget planning and monitoring through cost and spending analysis
Qualifications:
Required qualifications:
- Bachelor’s degree
- Minimum of 7 years' experience in the medical device industry
- Minimum of 3 years' experience in a leadership role within the medical device industry
Preferred qualifications:
- Experience leading audits, including front room and back room support
- Knowledge of U.S. and international regulatory reporting requirements
- Experience working with competent authorities
- Strong management and communication skills
- Project management experience
- Proven team leadership experience
- Experience with endoscopy products
- Experience with post-market surveillance activities
- Vendor management experience
Requisition ID: 628719
Minimum Salary: $ 106800
Maximum Salary: $ 202900
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.
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 www.bostonscientific.com 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 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.
Nearest Major Market: Boston
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