About this opportunity
Intracept by Boston Scientific lists this Product Complaint Analyst III opportunity in maple grove, Minnesota. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Urology Complaint Management Center Role
This role supports the Urology Complaint Management Center (CMC) in a fast-paced environment, analyzing customer complaints to determine regulatory reportability and coordinating activities with internal teams, field representatives and end-use customers. Products within scope include men's prosthetic urology, sacral and tibial neuromodulation for incontinence, prostate health, and surgical lasers.
The role is responsible for adherence to Good Manufacturing Practices (GMPs), proper complaint handling in accordance with the Code of Federal Regulations (CFR) and other applicable governmental regulations, and communication of event investigation results through regulatory reports and written communications, as appropriate.
Your responsibilities will include:
Review complaint communications and assess regulatory compliance, reportability and potential impact on patient safety and business operations.
Apply clinical knowledge related to product applications to evaluate identified complaints. Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees and laboratory analyses.
Establish regulatory reportability decisions using event investigation and regulatory decision models.
Participate in the development and modification of decision models as products and therapies advance to support consistent compliance with government-mandated regulations.
Write Medical Device Reports (MDRs), MedWatch reports, Vigilance reports and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities.
Apply codes to events to facilitate product performance records. Review coding and investigations with engineering, laboratory and other internal staff.
Compose written communications detailing clinical observations, investigations and/or product analyses and corrective actions, as applicable, for physicians and other end-use customers.
Review and approve work completed by the team.
Qualifications:
Required qualifications:
University degree or equivalent education.
Minimum of 5 years' experience in medical device complaint handling.
Self-motivated, goal-driven and results-oriented approach with the ability to work effectively as part of a team.
Excellent written and verbal communication skills.
Ability to apply critical thinking.
Excellent time-management skills.
Preferred qualifications:
College degree with a focus in biology, health sciences, biotechnology or engineering.
Experience with SAS, Power BI or TrackWise applications.
Experience reviewing scientific literature.
Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.
Worksite address
maple grove, MN, 55311, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.