Product Complaint Analyst III
Boston Scientific Gruppe, Arden Hills, MN, United States
Additional Location(s):
US-MA-Marlborough
About the role The Product Analyst III operates in a fast‑paced, evolving, and dynamic environment, analyzing customer feedback to support complaint determination. This role utilizes Hazard Analysis (HA) and Design Failure Mode and Effects Analysis (DFMEA) to review and process Complaint Management Center (CMC) decision rationale statements. The Product Analyst III performs good faith efforts and coordinates activities with internal teams, field personnel, and end‑use customers. As a Product Analyst III, you’ll write Medical Device Reports (MDR) and Medical Device Vigilance (MDV) regulatory submissions for the Urology Complaint Management Center (CMC). Additionally, you will communicate event investigation results through regulatory reports and other written communications, as appropriate. Products within scope include Men’s Prosthetic Urology, Prostate Health, and Surgical Lasers. As a PA3 you’ll ensure compliance with Good Manufacturing Practices (GMPs), divisional Standard Operating Procedures (SOPs), Work Instructions (WIs), and proper complaint handling in accordance with 21 CFR Part 820, EU MDR, MDSAP, ISO 13485, and other applicable regulatory requirements.
Location Note : 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.
Responsibilities
Perform thorough review of regulatory assessment, MDR/MDV and provide complaint owners with feedback per CMC SOPs and WI.
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 regulatory reportability decisions using HA, DFMEA, reported event, investigation and regulatory decision models.
Author Medical Device Reports (MDRs), MedWatch, Vigilance, 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 the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to physician and other end‑use customers.
Collaborate on new ideas and when needed participate in divisional improvement projects.
Provide support as a subject‑matter expert for divisional products, audit readiness, NCEP/CAPA investigation and ownership.
Required Qualifications
Minimum of a Bachelor’s degree.
Minimum of 3 years of experience in medical device complaint handling.
Preferred Qualifications
Excellent written and verbal communication, critical thinking, and time‑management skills.
Prior complaint handling experience for urological or laser devices.
Proficiency in a second language.
Proficiency with SAS, PowerBI, or TrackWise applications.
Experience working collaboratively with cross‑functional and global partners.
Safety‑Sensitive Position : This role is deemed safety‑sensitive and requires a prohibited substance test.
COVID‑19 Vaccination Requirement : Certain US‑based positions require acceptable proof of COVID‑19 vaccination status. Candidates will be notified of this requirement during the interview and selection process.
Requisition ID:
625888
Minimum Salary:
$65,800
Maximum Salary:
$125,000
Nearest Major Market:
Minneapolis
Job Segment:
Compliance, Urology, Law, Laboratory, Developer, Legal, Healthcare, Science, Technology
Equal Employment Opportunity Statement : Boston Scientific Corporation is an equal opportunity employer. All personnel decisions are made without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.
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US-MA-Marlborough
About the role The Product Analyst III operates in a fast‑paced, evolving, and dynamic environment, analyzing customer feedback to support complaint determination. This role utilizes Hazard Analysis (HA) and Design Failure Mode and Effects Analysis (DFMEA) to review and process Complaint Management Center (CMC) decision rationale statements. The Product Analyst III performs good faith efforts and coordinates activities with internal teams, field personnel, and end‑use customers. As a Product Analyst III, you’ll write Medical Device Reports (MDR) and Medical Device Vigilance (MDV) regulatory submissions for the Urology Complaint Management Center (CMC). Additionally, you will communicate event investigation results through regulatory reports and other written communications, as appropriate. Products within scope include Men’s Prosthetic Urology, Prostate Health, and Surgical Lasers. As a PA3 you’ll ensure compliance with Good Manufacturing Practices (GMPs), divisional Standard Operating Procedures (SOPs), Work Instructions (WIs), and proper complaint handling in accordance with 21 CFR Part 820, EU MDR, MDSAP, ISO 13485, and other applicable regulatory requirements.
Location Note : 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.
Responsibilities
Perform thorough review of regulatory assessment, MDR/MDV and provide complaint owners with feedback per CMC SOPs and WI.
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 regulatory reportability decisions using HA, DFMEA, reported event, investigation and regulatory decision models.
Author Medical Device Reports (MDRs), MedWatch, Vigilance, 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 the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to physician and other end‑use customers.
Collaborate on new ideas and when needed participate in divisional improvement projects.
Provide support as a subject‑matter expert for divisional products, audit readiness, NCEP/CAPA investigation and ownership.
Required Qualifications
Minimum of a Bachelor’s degree.
Minimum of 3 years of experience in medical device complaint handling.
Preferred Qualifications
Excellent written and verbal communication, critical thinking, and time‑management skills.
Prior complaint handling experience for urological or laser devices.
Proficiency in a second language.
Proficiency with SAS, PowerBI, or TrackWise applications.
Experience working collaboratively with cross‑functional and global partners.
Safety‑Sensitive Position : This role is deemed safety‑sensitive and requires a prohibited substance test.
COVID‑19 Vaccination Requirement : Certain US‑based positions require acceptable proof of COVID‑19 vaccination status. Candidates will be notified of this requirement during the interview and selection process.
Requisition ID:
625888
Minimum Salary:
$65,800
Maximum Salary:
$125,000
Nearest Major Market:
Minneapolis
Job Segment:
Compliance, Urology, Law, Laboratory, Developer, Legal, Healthcare, Science, Technology
Equal Employment Opportunity Statement : Boston Scientific Corporation is an equal opportunity employer. All personnel decisions are made without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.
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