Senior Product Quality & Compliance Analyst

Boston Scientific; Santa Clarita (CA); Hybrid; USD 72,000 - 136,000; Full time

Job summary

Boston Scientific is seeking a Senior Product Analyst to join the Neuromodulation Division’s Complaint Management Center. You will analyze customer complaints, collaborate with cross-functional partners, and apply data-driven insights to identify risks and drive improvements across global markets.

This hybrid role emphasizes regulatory compliance, documentation, and clear communication with physicians and end users, with a focus on patient safety and product quality.

Qualifications

• Bachelor’s degree in a scientific, technical or related discipline.
• Minimum of 5 years' experience in the medical device industry.
• Proficiency with FDA, ISO and other medical device regulations.

Responsibilities

• Serve as a positive influence on team culture by modeling high-quality work, effective communication, resilience and solution-oriented thinking.
• Ensure compliance with U.S. and international regulatory requirements for medical device complaint handling and regulatory reporting.
• Review complaint communications and assess regulatory compliance, reportability and potential impact to patient safety and business operations.
• Apply clinical knowledge related to product applications to evaluate complaints and conduct investigations.
• Establish regulatory reportability decisions using hazard analyses and DFMEA.
• Apply coding to complaint events to support product performance records and review outcomes with cross-functional teams.
• Compose written communications detailing observations, investigations and corrective actions for physicians and end users.
• Support and lead divisional initiatives and strategic priorities.
• Review peer work products and identify opportunities for process improvement.
• Use data analytics to identify risks, opportunities and business priorities.

Skills

Regulatory compliance

Data analysis

Cross-functional collaboration

Clinical knowledge

Communication skills

Education

Bachelor’s degree in a scientific, technical or related discipline

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Boston Scientific is seeking a Senior Product Analyst to join the Neuromodulation Division’s Complaint Management Center. You will analyze customer complaints, collaborate with cross-functional partners, and apply data-driven insights to identify risks and drive improvements across global markets.

This hybrid role emphasizes regulatory compliance, documentation, and clear communication with physicians and end users, with a focus on patient safety and product quality.