Product Complaint Supervisor

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: 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.

• 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), Med Watch, Vigilance, and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities.

• 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

• 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
• Excellent time management and organizational abilities
• Experience with SAS, Power
  
  BI, or Track Wise applications
• Experience with Electrophysiology products

Requisition

Minimum Salary:$65800

Maximum Salary: $125000

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