Senior Product Quality & Compliance Analyst

Boston Scientific; Arden Hills (MN); Hybrid; USD 72,000 - 136,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Boston Scientific is seeking a Senior Product Complaint Analyst to drive compliant, timely handling of customer complaints and regulatory reporting across global markets. You will evaluate investigations, prepare MDRs/MDVs, and support post-market surveillance within the Cardiac Diagnostics team.

The role requires a minimum of 5 years in medical device complaint handling or related regulatory functions, with a strong emphasis on GMP, ISO and FDA regulations.

Qualifications

• Associate’s degree in a scientific, technical, or related field, plus relevant industry experience; or a Bachelor’s degree in a scientific, technical, or related field.
• Minimum of 5 years' experience in complaint handling, post-market surveillance, quality, regulatory affairs or a related function within the medical device industry.
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint).
• Working knowledge of FDA, ISO and other applicable medical device regulations.

Responsibilities

• Review complaints and regulatory assessments to determine reportability, compliance and potential impact on patient safety and product quality.
• Investigate complaints by gathering and analyzing information from clinical staff, field representatives, internal stakeholders and laboratory evaluations.
• Establish regulatory reporting decisions using hazard analyses, DFMEAs, investigation findings and regulatory decision models.
• Author and submit MDRs, MDVs, MedWatch reports and other regulatory submissions in accordance with global regulatory requirements.
• Apply and review complaint coding to support accurate product performance trending, and collaborate with engineering, laboratory and cross-functional teams on investigation outcomes.
• Prepare clear, concise written communications summarizing complaint investigations, clinical assessments, product analyses and corrective actions.
• Serve as a subject matter expert for complaint handling, product performance and regulatory reporting requirements.
• Support audit readiness activities, inspections, CAPA investigations, NCEP activities and other quality system processes.
• Leverage data and analytics to identify trends, emerging risks and opportunities for process and product improvement.
• Lead and support strategic initiatives and continuous improvement projects that enhance quality system effectiveness and operational performance.

Skills

Analytical skills

Communication skills

Regulatory knowledge

Problem solving

Education

Associate's degree in scientific/technical field

Bachelor's degree in scientific/technical field

Tools

Microsoft Office (Word, Excel, PowerPoint)

Job description

Boston Scientific is seeking a Senior Product Complaint Analyst to drive compliant, timely handling of customer complaints and regulatory reporting across global markets. You will evaluate investigations, prepare MDRs/MDVs, and support post-market surveillance within the Cardiac Diagnostics team.

The role requires a minimum of 5 years in medical device complaint handling or related regulatory functions, with a strong emphasis on GMP, ISO and FDA regulations.