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Boston Scientific seeks a Senior Product Complaint Analyst to join the Cardiac Diagnostics Complaint Management Team. This role is critical to maintaining product quality, patient safety, and regulatory compliance across global markets.
You will evaluate and investigate customer complaints, prepare Medical Device Reports (MDRs) and Medical Device Vigilance (MDV) submissions, and support post-market surveillance activities. Working with cross-functional partners including clinical staff, field representatives, engineering, and laboratory teams, you will resolve complex product and quality issues while ensuring timely, accurate, and compliant complaint handling.
Key responsibilities include reviewing complaints to determine reportability and patient safety impact; investigating complaints through data gathering and analysis; establishing regulatory reporting decisions using hazard analyses and DFMEAs; authoring and submitting MDRs, MDVs, and MedWatch reports; applying complaint coding for product performance trending; preparing clear written communications on investigations and corrective actions; serving as a subject matter expert on complaint handling and regulatory reporting; supporting audit readiness and CAPA investigations; leveraging data analytics to identify trends and risks; leading continuous improvement initiatives; providing guidance and training to peers; and communicating risks and findings to leadership.
You will maintain compliance with Good Manufacturing Practices (GMPs), Standard Operating Procedures (SOPs), and applicable global regulatory requirements including 21 CFR Part 820, EU MDR, MDSAP, and ISO 13485. This hybrid role requires three days per week in the local office.
Required: Bachelor's degree in a scientific, technical, or related discipline; minimum 5 years' experience in complaint handling, post-market surveillance, quality, regulatory affairs, or related medical device industry function; proficiency with Microsoft Office; working knowledge of FDA, ISO, and applicable medical device regulations.
Preferred: CAPA experience; medical device complaint handling experience; strong research, communication, and presentation skills; technical writing and documentation skills; ability to work independently; adaptability to changing priorities; data analytics experience; proven ability to influence cross-functional stakeholders.
