The Opportunity

As our Senior Complaint Specialist, you will play a critical role in ensuring the safety and regulatory integrity of our products after they reach clinicians and patients. You will be responsible for the end-to-end management of product complaints, ensuring that every report is handled with the highest level of technical accuracy and regulatory compliance. This role is a key pillar of our post-market surveillance strategy, bridging the gap between customer feedback and continuous quality improvement.

Job Description:

The Senior Complaint Specialist requires experience in the medical device industry with a clear understanding of medical device complaint handling processes, trending, and regulatory reporting procedures. This role will be responsible for identifying, reviewing, and processing complaints for evaluation as required by applicable regulations, standards, and company procedures. This role serves as a primary subject matter expert for complaint escalations and ensures that all reporting requirements to domestic and international regulatory authorities are completed accurately and on time.

Job Responsibilities:

• Complaint Handling: Assess reports received through multiple customer feedback channels to identify alleged deficiencies, ensure accurate documentation, and manage timely complaint review and closure.
• Regulatory Reporting: Ensure timely and accurate Medical Device Reporting (MDR) and adverse event reporting to external regulatory authorities as required to ensure compliance with global regulatory requirements, including but not limited to FDA (21 CFR 820, 803, 806) and EU MDR.
• Data Analysis & Statistical Trending: Collect, evaluate, and analyze complaints data to identify trends, potential risks, and opportunities for product improvement.
• Quality System Support: Provide support on the maintenance of department documents and procedures; participate in Quality Management System (QMS) activities and Risk Management activities, including Health Hazard Evaluations (HHE), CAPA, and Nonconformance Reports (NCR).
• Field Actions & Recalls: Provide support on product field action activities, including identification, risk assessment, stakeholder communication, and coordination of corrective actions.
• Cross-Functional Liaison: Assist Customer Support and serve as a technical liaison for complaint escalations, providing support on complaint closure approvals; Provide guidance and mentorship to team members on process execution and regulatory requirements.
• Process Optimization: Identify efficiencies in our surveillance workflows to scale our operations

Skills Needed:

• Regulatory Knowledge and deep understanding of 21 CFR 820, 21 CFR 803, 21 CFR 806, EU MDR, Health Canada MPR, ISO13485, and ISO 14971
• Proficient with Salesforce, Tableau, Electronic Document Management Systems (EDMS), Google Workspace, and MS Office
• Strong critical thinking skills and great attention to detail
• Ability to work as a self-starter in a fast-paced, adaptive environment and mentor team members
• Excellent communication, documentation, and time management skill
• Ability to stay current with global regulatory requirements and industry best practices

Educational Requirements & Work Experience:

• Education: Bachelor’s degree in Science, Engineering, or a related field.
• Experience: 5+ years of relevant experience in the medical device industry, software medical device products (class II/III) preferred.

This position has an estimated base salary of $75,000 to $100,000 and bonus. #LI-IB1; #LI-Hybrid