Primary responsibility is to support the global reporting obligations and the management of communication between manufacturer, distributors and competent authorities for all medical device complaint related activities, including assistance of and/or submission of medical device event reports in accordance with applicable local laws and regulations.
Provide understanding , leading analysis and management of information regarding medical device complaint events and/or adverse events, follow-up, case processing and assessment for post-marketing activities including:
- Receives, documents and evaluates complaint information
-As required, communicates with physician, physician’s staff and/or patient to obtain pertinent complaint information.
-Evaluates and engages appropriate management for critical and/or unusual events.
-Liaises with internal functions (Quality, Regulatory, Medical Affairs, Customer Service, Manufacturing and R&D) to gather critical input into medical device event reports.
-Reviews complaint manufacturing investigation reports and provides comments in accordance with procedures.
-Ensures complaints are processed in a timely manner
-Reviews and closes complaint files.
-Compiles case and process metrics.
Performs and/or documents regulatory reportability decisions on complaints in accordance with applicable local laws regulations.
Communicates with local and international competent authorities, including generation and/or submission of medical device event reports as required by applicable local laws and regulations.
Assists local affiliates with the preparation and submission of medical device complaints and or incident reports, when required.
Coordinates and prepares responses to competent authority inquiry’s associated with medical device report submission (Serious Injury and/or Device Malfunction).
Participate in preparation for Notified Body audits and or Competent Authority inspections.
When required, support root cause investigations and participates in CAPA (Corrective and Preventive Action) activities.
Supports complaint handling trending activities.
Generates complaint data reports for other departments, when requested.
As required, supports department projects and/or participates in cross functional projects.
Generates periodic reports as requested per government agencies and/or Notified Bodies.
Performs all other duties as assigned.
SUPERVISE DIRECT REPORTS
SCOPE OF POSITION
The scope of this position is directly related to global complaint management and adverse event reporting responsibilities for all company medical device products as assigned.
The position will include interaction and communication with doctors and patients as well as internal business stakeholders.
Internal customers/business partners:
Research and Development
Design Quality Assurance
External Manufacturing Quality Assurance.
Manufacturing Site Quality Assurance
External customers/business partners:
Physicians (including physician’s staff)
Audit/Inspection Organizations (FDA, Notified Bodies, International Regulatory Agencies)
Bachelor‘s degree in scientific or business related discipline required (Biomedical, , Engineering, Science, etc.).
Knowledge of ophthalmic medical terms, Medical Device Reporting regulations, Vigilance Reporting regulations, GMPs for medical devices preferred.
Position requires strong written, oral and listening communication skills in order to interact with customer and other professionals.
Must be able to generate and organize clear, concise responses when communicating with various levels of management.
Superior organizational skills to be able to manage challenging deadlines.
Adjusts to change with minimum or no interruption.
Recognizes problems and suggests applicable solutions.
Able to perform job function with minor supervision and make independent decisions, where appropriate.
Proficient in the use of personal computers, including database management, trending and word processing.
Minimum of 3-5 years related work experience is required.