Senior Complaint Specialist

Anika Therapeutics•Bedford, MA

About The Position

The Senior Complaint Specialist ensures global complaint handling activities comply with ISO, FDA, EU MDR 2017/745, and MDSAP requirements. This role manages the full lifecycle of medical device complaints, including intake, evaluation, investigation, regulatory reporting, resolution, and closure, while ensuring compliance, timely execution, and high-quality documentation. In this role, you serve as a subject matter expert in complaint handling, medical device reporting, and post-market quality systems. This role operates in a highly regulated, data-driven quality environment requiring independent judgment, technical evaluation, and regulatory decision-making. The Senior Complaint Specialist must analyze complex product quality issues across multiple global sites, determine regulatory reporting obligations, and ensure compliance with FDA, ISO, and EU MDR requirements. The position requires strong investigative capability, the ability to interpret technical and clinical data, and sound decision-making in determining product risk and patient safety implications. Errors in judgment or documentation may result in regulatory non-compliance, delayed reporting, or patient safety risk.

Requirements

Bachelor’s degree in Engineering, Life Sciences, or related discipline, or equivalent experience.
Minimum of 3+ years of direct experience in complaint handling and quality systems documentation.
Strong knowledge of FDA regulations including 21 CFR Part 820 and 21 CFR Part 211.
Working knowledge of ISO 13485, EU MDR 2017/745, and global medical device regulatory requirements.
Experience with complaint handling, investigations, root cause analysis, and documentation of quality events.
Experience supporting CAPA and Change Control processes within a regulated environment.
Familiarity with design control principles and risk management concepts (ISO 14971).
Strong analytical and problem-solving skills with the ability to interpret technical and quality data.
Experience using complaint management systems and quality management databases.
Strong written and verbal communication skills with the ability to produce clear, compliant technical reports.
Proficiency with Microsoft Office tools, including spreadsheets and databases.

Nice To Haves

Knowledge of statistical process control (SPC) methods and techniques.
Experience with statistical software tools and data analysis.
Working knowledge of Six Sigma methodologies.
Experience supporting internal/external audits and supplier quality audits.
Strong experience in trending analysis and development of quality metrics dashboards.
Demonstrated ability to work independently, manage competing priorities, and deliver results on time.
Strong presentation and cross-functional communication skills.
Experience supporting global post-market surveillance systems and reporting frameworks.

Responsibilities

Manage the end-to-end lifecycle of global customer complaints across multiple sites, ensuring compliance with applicable regulatory requirements and internal procedures.
Perform complaint intake, assessment, investigation, resolution, and final customer communication for medical device and product quality issues.
Evaluate complaints for Medical Device Reporting (MDR) and determine reporting requirements in accordance with FDA, ISO, and global regulatory expectations.
Conduct root cause analyses, lead complaint investigations, and prepare detailed, high-quality investigation reports.
Utilize complaint management systems to document, track, trend, and report complaint data and quality metrics.
Monitor complaint trends and escalate potential quality or safety signals to management for timely action.
Support Post Market Surveillance activities, including data collection, trending analysis, and regulatory reporting inputs.
Collaborate with internal and external stakeholders (e.g., clinical sites, physicians, hospitals, sales representatives, and suppliers) to gather complaint-related information.
Assist in the development and maintenance of complaint metrics, dashboards, and management reporting.
Support CAPA and Change Control processes, including investigation support, documentation, and effectiveness verification.
Ensure integration of risk management principles in accordance with ISO 14971 and alignment with design and process controls.
Participate in internal and external audits as a subject matter expert in complaint handling processes.
Support continuous improvement initiatives for the global complaint handling and post-market quality systems.
Maintain accurate complaint files and ensure compliance with good documentation practices (GDP).
Serve as a trainer and SME for complaint handling processes within the Quality organization.
Perform other duties and projects as assigned.