Philips PMS Regulatory Affairs Specialist in Haifa, Israel
The Post Market Surveillance Regulatory Affairs Specialist is responsible for FCO being in compliance including monitors and coordinates recall/field corrective action programs for medical and consumer products.
Prepares required documentation of field actions e.g., Health Hazard Evaluation documents, Correction and Removal documents, and product recall files.
Establish control and maintenance of all quality processes and measures related to Field Action.
Ensures that processes for specifying and executing field actions are adequate to ensure the expectations of all key stakeholders are met.
Monitors and coordinates the different sub-system feeders to this process such as complaint handling, engineering change orders, kit suppliers, regulatory submission and field deployment.
Prepares key documents such as Health Hazard Evaluation documents, Correction and Removal documents, product recall files and various internal reports.
Ensures alignment between risk assessment and management documentations and documentation for field actions.
Manages recall responses, recall file documentation and recall file completion.
Provides relevant feedback and insights from customers/filed to development/engineering teams to ensure learnings from previous projects are captured, synthesized and made available for next project teams.
Continuously tracks field actions and provide ongoing information to Regulatory Operations as required.
Establishes, monitors and reports on metrics on the efficacy and efficiency of field action processes. Requirements
Relevant academic degree.
Experience in Quality (at least 6 months).
Experience working in Medical device company – an advantage.
Knowledge of FDA Regulations - an advantage.
Good verbal and written communication skills in English.