Product Complaint Analyst III

Product Complaint Analyst III

Work mode: Hybrid Onsite Location(s): Arden Hills, MN, US, 55112 Additional Location(s): US-MN-Arden Hills; US-MA-Marlborough; US-MN-Maple Grove 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.

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 Product Analyst III 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. 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 responsibilities will include:

• Perform thorough review of regulatory assessment, MDR/MDV and will 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 in the following areas: subject matter experts 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
• Experienced working collaboratively with cross-functional and global partners

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