Product Complaint Analyst III

bostonscientific•Valencia, MN

1d•Hybrid

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

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).

Benefits

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.
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).
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.