Product Complaint Analyst II
About The Position
About the role: The Product Complaint Analyst II analyzes customer complaints to determine which are regulatory reportable and coordinates activities with internal, field, and end use customers. Responsible for adherence to Good Manufacturing Practices (GMPs) and proper complaint handling per the Code of Federal Register (CFR) and other governmental regulations. Communicates 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.
Requirements
- Bachelor's degree
- Minimum of 2 years of experience in a health care, clinical, technical, scientific, and/or related field
Nice To Haves
- Knowledge of Left Atrial Appendage Closure medical devices
- Experience with TrackWise -based complaint handling system
- Submissions of MDRs and MDVs
- Experience evaluating and investigation patient complication/death events
- Medical device industry experience
- Post market/Quality
- Attention to detail
- Critical thinking skills
- Excellent written and verbal communication skills
- self-motivated, goal-driven and results-oriented team player
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.
- Establish 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.
- Write 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. Communications include determination/eligibility for warranty credit or unreimbursed medical payments.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Merchant Wholesalers, Durable Goods
Number of Employees
5,001-10,000 employees
