Senior Product Complaint Analyst, Quality & Patient Safety

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

Job summary

Boston Scientific Corporation is seeking a Senior Product Analyst to enhance product quality and performance globally. The role analyzes neuromodulation complaints, collaborates with cross-functional partners, and uses data-driven insights to drive improvements in safety and effectiveness.

The position emphasizes regulatory compliance, detailed investigations, and impactful written communications to physicians and stakeholders, with a hybrid work model based in the U.S. facilities.

Qualifications

• Bachelor’s degree in a scientific, technical or related discipline.
• Minimum 5 years’ experience in the medical device industry.
• Strong knowledge of FDA, ISO and other applicable medical device regulations.
• Proven ability to analyze complaints, investigations and regulatory reporting.

Responsibilities

• Review complaint communications and assess regulatory compliance and reportability.
• Apply clinical knowledge to evaluate identified complaints and conduct investigations.
• Establish regulatory reportability decisions using hazard analyses and DFMEA.
• Code complaints accurately and collaborate with engineering and labs on outcomes.
• Prepare clear written communications for physicians and end users.
• Use data analytics to identify risks and inform leadership decisions.

Skills

Regulatory compliance

Data analytics

Technical writing

Communication skills

Presentation skills

Microsoft Office

FDA/ISO regulations

Process improvement

Education

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

Tools

Microsoft Office

Job description

Boston Scientific Corporation is seeking a Senior Product Analyst to enhance product quality and performance globally. The role analyzes neuromodulation complaints, collaborates with cross-functional partners, and uses data-driven insights to drive improvements in safety and effectiveness.

The position emphasizes regulatory compliance, detailed investigations, and impactful written communications to physicians and stakeholders, with a hybrid work model based in the U.S. facilities.