Product Complaint Supervisor
About The Position
Oversees and supervises product complaint analyst personnel to meet the activities of the Complaints Management Center Department. Analyzes customer complaints to determine which are regulatory reportable and coordinates activities with internal, field, and end use customers. Responsible for adherence to Good Manufacturing Practices (GMPs) and proper complaint handling per the Code of Federal Register (CFR) and other governmental regulations. Communicates event investigation results via regulatory reports and written communications, as appropriate. 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. Relocation assistance is not available for this position at this time. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.
Requirements
- Bachelor’s degree, or an equivalent combination of education and experience in lieu of a degree
- Minimum of 3+ years of medical device or regulated industry experience
Nice To Haves
- Degree in Biology, Health Sciences, Biotechnology or Engineering
- Self-motivated, goal-drive, and results-oriented team player
- Strong written and verbal communications skills
- Direct or indirect leadership experience
- Prior complaint handling experience
- Excellent time management and organizational abilities
- Experience with SAS, PowerBI, or TrackWise applications
- Experience with Electrophysiology products
Responsibilities
- Supervising a small team of product analysts to meet the objectives established by the Department Manager.
- Monitoring daily operations and work-in-progress (WIP) to ensure efficiency and adherence to quality standards and regulatory requirements.
- Supporting the professional development of individual contributors, helping them grow their skills and advance their careers.
- Coordinating efforts with corporate partners and liaising with multiple geographical locations to align strategies and achieve common goals.
- Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
- Apply clinical knowledge, as related to product application, to evaluate identified complaints. Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.
- Establish and approve regulatory reportability decisions using event investigation and regulatory decision models.
- Participate in development and modification of these decision models with changes in product advances/therapies to uphold consistent compliance with government-mandated regulations.
- Write and approve Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
5,001-10,000 employees
