Product Complaint Analyst I

About the role

The Product Complaint Analyst I supports Boston Scientific by reviewing customer complaints, determining regulatory reportability, and coordinating investigations with internal and external stakeholders. This hybrid position blends on‑site work in Heredia, Costa Rica with remote flexibility.

Key responsibilities

• Review complaint communications for regulatory compliance, reportability, and impact on patient safety.
• Develop and update decision models as product therapies evolve.
• Gather data from clinical staff, field representatives, internal teams, and laboratories to investigate complaints.
• Document regulatory decisions and draft Medical Device Reports (MDRs), MedWatch, Vigilance, and other required reports.
• Apply coding to events, collaborate with engineering and laboratory staff, and maintain product performance records.
• Prepare written communications for physicians and end‑use customers, including warranty and reimbursement determinations.
• Assist with receipt, processing, and evaluation of returned devices and support engineering change procedures.
• Provide monthly complaint updates in accordance with internal procedures.

Required profile

• Experience analyzing customer complaints and conducting investigations.
• Familiarity with Good Manufacturing Practices (GMP) and Code of Federal Regulations (CFR) for medical devices.
• Ability to compile and communicate regulatory findings clearly.
• Strong attention to detail and ability to work with cross‑functional teams.

Required skills

• Good Manufacturing Practices (GMP) knowledge
• Regulatory reporting (MDR, MedWatch, Vigilance)
• Event coding and documentation
• Use of investigation and decision‑making models

What we offer

• Hybrid work environment with flexibility
• Opportunity to contribute to patient safety and product quality
• Collaboration with global teams in a leading medical‑device company