The Director, Product Surveillance will provide strategic and tactical direction regarding post-market product surveillance.
Post-market product surveillance includes reactive surveillance generated from products used in the field (complaints), as well as proactive surveillance generated from information in the scientific literature and information obtained from manufacturing and quality system activities, including CAPA and risk management activities.
The Director role provides strategic leadership and supervision of the Product Surveillance team in the execution of timely, high quality and consistent product complaints management, including appropriate identification and response to risks, adverse event reporting decisions, and collection and documentation of complaints. The scope of responsibility includes leadership for directing all Post Market Surveillance activities.
Supervise, monitor, and engage Product Surveillance staff, while also managing the organizational structure and staffing for the Product Surveillance Team to ensure the management of product complaints is executed according to regulatory requirements and customer expectations.
Harmonize the complaint handling process, ensure regulatory compliance, and drive continuous improvement within the product surveillance teams
Establish and maintain strong relationships to enforce customer feedback investigations and to ensure that adequate corrective actions are being implemented in a timely manner, acting appropriately when things need to be escalated for senior management involvement.
Lead interactions with other functions as required with respect to customer feedback investigation, assessing appropriateness of investigations and corrective actions.
Lead the monitoring of the customer feedback and safety profile of products, including signal detection, and management of signal evaluation activities and documentation
Use risk management skills to analyze adverse event information and determine if further adverse health outcome details are required for reportability decision-making, and determine if events are reportable to regulators.
Manage the preparation of aggregate customer feedback reports, and consequent review of Risk Management Plans, relevant sections of regulatory documents and health authority responses
Provide scientific input into evaluation of customer feedback
Provide scientific input into safety documents and relevant sections of regulatory documents such as safety analyses, expert statements, submission dossiers, health authority responses, clinical study reports and protocols.
Oversee development of safety data reviews for Clinical Evaluation Reports, Annual Reports and Health Hazard Assessments
Qualifications, Skills and Experience Required
Bachelor’s Degree in an Engineering, Science or related discipline
Minimum of ten (10) years of experience with Post-Market Surveillance /Customer Complaints concepts, principles and systems
Minimum of five (5) years of experience in the medical device industry, preferably with PMA devices
Knowledge of FDA Quality System Regulations (21 CFR Part 820) and ISO13485.
Working knowledge of product risk management for both pre-market development activities and post-market safety surveillance activities
Demonstrated ability to organize, prioritize and manage safety compliance deliverables with a focus on patient safety and regulatory compliance.
Previous experience in scientific/medical writing is desired
Ability to read and analyze scientific and medical literature
Experience building, growing and developing a post market surveillance team
Ability to lead and manage at all levels of the organization.
Strong analytical skills and attention to detail
Strong project management and strategic planning skills
Excellent interpersonal and communication skills, including proven verbal, written, and presentation skills
Internal Number: 1Reg
About Flowonix Medical Inc.
At Flowonix, our patient centric approach drives the design, development, and deployment of targeted drug delivery platforms whose sole purpose is to provide physicians an optimal solution for the treatment of their patients' numerous neurological disorders.