Product Complaint Analyst III

Product Complaint Analyst III

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.

The Product Complaint Analyst III will critique customer complaints to determine which are regulatory reportable and coordinates activities with internal, field, and end use customers. Act as divisions expert in assigning our complaints (WIP coordinator). They will be responsible for adherence to Good Manufacturing Practices (GMPs) and proper complaint handling per the Code of Federal Register (CFR) and other governmental regulations. Approve 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.

Your key responsibilities will include:

• 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.
• Examine 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.
• Review Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities.
• Review coding and investigations with engineering, laboratory, and other internal staff.
• Coordinate WIP activities for complaint owners including assignment, processing opportunities, tackling roadblocks, and monitoring team dashboards for escalation
• Track and develop tools and resources, including PowerBI and SAS.
• Improve upon existing tools and resources, including but not limited to, automation (e.g., power automate, macros).

Required Qualifications:

• Minimum of a Bachelors degree
• Minimum of 3 years of related experience
• Medical device or other regulated industry experience required

Preferred Qualifications:

• Self-motivated, goal-driven and results-oriented team player
• Experience with SAS, PowerBI, or TrackWise application

Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.