Regulatory Complaint Specialist
|Employment Type:||Full Time|
|Department:||Quality & Regulatory|
The Regulatory Complaint Specialist is responsible for the ongoing administration, maintenance and continuous improvement of the Complaint Handling process to ensure compliance with global complaint handling and device reporting requirements. Responsible for the timely completion of assigned activities related to regulatory compliance support activities worldwide, such as completion of regulatory reporting decision trees, submission of Medical Device Reports (FDA Form 3500A), trend analyses and complaint closure customer communication.
- Maintains complaint systems software and database.
- Analyzes, assesses and recommends improvements of the complaint management process.
- Prepares and submits medical device reports (MDR - FDA Form MedWatch 3500A, 21 CFR 803).
- Proactively distributes important product and/or medical information to relevant internal functions as necessary in support of product changes, safety issues and other sentinel events.
- Responds to both written and phone inquiries from health care professionals, patients and consumers.
- Disseminates relevant product complaint information within the organization on a consistent basis.
- Compiles statistical analysis of product complaints; prepare trend analysis, and contributes to management reports on the effectiveness of the complaint management system.
- Participates in risk analysis (i.e., establishing risk documents such as hazard analysis and FMEA).
- Contributes to the development and maintenance of standard and custom product information responses in various formats to address vast array of inquiries.
- Participates in complaint process SOP writing and ensures that all employees are trained on the complaints processes.
- Participates in global Field Corrective Action and Recall Assessments and actions as required
- Participates in audits including, internal, US FDA and ISO 13485:2003.
- Plans, schedules and completes projects in an aggressive "sense of urgency manner" consistent with corporate objectives.
- Participates in regulatory reviews, compliance gap analyses, implementation planning and project management to ensure compliance with applicable regulatory requirements.
- Other duties as assigned.
General Skills/Competencies/Specialized Knowledge
Demonstrates understanding of manufacturing operations and scientific processes to assist with investigations, documentation and reporting.
Must be able to review systems, processes and policies to ensure compliance with required quality system and clinical practices.
Critical Thinking and Problem Solving Skills
Uses skills of observation, interpretation, analysis, inference, evaluation, and explanation to support a decision.
Basic understanding of statistical tools.
Identifies and understands relevant trends, opportunities, needs, and market direction within the medical device industry.
Strong technical and analytical skills; uses rigorous logic and methods to solve difficult problems with effective solutions.
Proven ability to analyze and interpret data, to provide guidance, data driven decisions, and recommendations to internal customers, contract manufacturers, and external suppliers.
Strong verbal and written communication skills.
Ability to communicate within all areas of the organization to facilitate audits, trainings, compliance and support corporate objectives.
Embraces and adapts to change and demonstrates a willingness to learn.
Reactionary and adaptable to abrupt changes, arising issues, extreme time pressures, and other exigent circumstances while effectively maintaining the state of control required for the Complaints Handling System effectiveness.
Generally works well with minimal supervision after receiving instructions and expectations.
Ability to prioritize work, goals and tasks consistent with the department and corporate objectives.
Ability to take direction from multiple sources and manage conflicting priorities in an effective and efficient manner.
Quick to evaluate circumstances and seek necessary information or resources to secure a full understanding of the situation and/or requirements to be resolved.
Ability to make compliance decisions independently.
Strong computer literacy.
Highly proficient in MS Word, Excel, PowerPoint, Outlook required.
Work Environment And Physical Demands
- Bachelor's degree in a related field (i.e., science or engineering field) required.
Minimum of 4 years' experience in management of complaint management processes in the medical device industry, i.e. QSR (21 CFR 820) and ISO/EC (MDD, ISO 13485), required.
Understanding of FDA regulations and reporting requirements for medical device complaints, including MDR reports.
Knowledge of EU Medical Device Directives, Canadian Medical Device Regulations and other International Regulations strongly preferred.
Knowledge of the requirements for international quality systems, including ISO 13485, MDD, Vigilance Systems, Notified Bodies, CE marking and IEC 60601.
Experience in interacting with health care professionals, patients, and consumers to complete and close complaint investigations.
Experience with complaint management software systems and databases preferred.
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