Product Complaint Manager

bostonscientific • Marlborough, MA

9d • Hybrid

About The Position

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. This role follows a hybrid work model requiring employees to be at our local office at least three days per week.

Requirements

• 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

Nice To Haves

• 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

Responsibilities

• 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

Benefits

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Senior