Senior Manager, Post Market Surveillance

Merit Medical Systems, Inc. is dedicated to creating innovative medical devices that improve lives. The Senior Manager of Post Market Surveillance will oversee quality management systems, manage personnel, and ensure compliance with regulatory standards while driving continuous improvement initiatives.

Responsibilities:

• Responsible for the following quality management sub-systems:
• Post Market Surveillance (PMS) documentation processes such as Periodic Safety Update Reports (PSUR) and Post Market Surveillance Reports (PMSR)
• Health Hazard Evaluation (HHE) Processes
• Field Correction Action and Recall (FCA) Processes
• Manages and supervises all post market surveillance personnel including interviewing, hiring, training, evaluating performance, coaching and disciplinary actions
• Designs, documents, implements, and maintains compliant quality management sub-systems to assure effective operational execution of assigned responsibilities across all Global sites and locations
• Develops, implements, and measures key performance metrics directly associated with effective operational execution of assigned responsibilities
• Provides Subject Matter Expertise and Training / development requirements and objectives for assigned areas of responsibility, specifically for appropriately evaluating returned medical device products for compliance to stated specifications and ascertaining any respective risks to patient safety
• Maintains Post Market Surveillance Documentation, Health Hazard Evaluation and Field Corrective Action and Recall systems focused on specific reporting timeliness and consistent, compliant process execution. Maintains PMS and FCA reporting compliance to all applicable regulation time requirements
• Maintains appropriate records for PMS, HHE and FCA reporting systems as defined in relevant procedures
• Establishes and maintains awareness of relevant regulations and standards to ensure the company's post-market surveillance practices align with industry requirements
• Participates in and, when needed, performs timely trend review of serious and non-serious events and reports to competent authorities as appropriate based on statistically significant trends that change the risk to benefit statement of products
• Works in close collaboration and partnership with cross functional and cross Site Global Quality Assurance stakeholders to optimize overall operational efficiency and effectiveness while maintaining and developing best in class quality systems
• Coordinates and interacts with various levels of management, international regulatory affairs/quality assurance, and global regulatory bodies on the adverse event reporting, customer complaints and Global PMS requirements and deliverables
• Authors timely, responsive, and evidenced based communication to regulatory authorities, notified bodies, customers, and external entities upon request
• Prepares for, participates in and assists with FDA facility inspections, Notified Body Audits, Post Market Surveillance activities and other governmental inspections as directed
• Drives continuous improvement initiatives based on post-market surveillance findings, contributing to product enhancements and risk mitigation strategies
• Performs other duties, as required

Requirements:

• Education and/or experience equivalent to a bachelor's degree in quality engineering / engineering / science, nursing or equivalent qualification essential (NFQ Level 7, or higher)
• At least twelve (12) years of work-related experience in the medical device industry, of which seven (7) years' should be in a related supervisory, leadership or management role
• Knowledge of U.S. FDA regulations (21 CFR 803, 806, 820), the Medical Devices Directive (93/42/EEC, as amended), the European Medical Device Regulation 2017/745 (MDR), ISO 13485 Quality System Standards, and Canadian Medical Device Regulation (CMDR), ANVISA, TGA and JPAL/JGMP
• Knowledge of ISO 14971 Risk Management related activities and requirements
• Demonstrated experience with electronic data management systems (e.g., Pilgrim, Oracle), computer skills preferably spreadsheets, word processing, database, internet research and other applicable software programs
• Excellent data, analysis, trends, and reporting skills. Ability to read and interpret documents. Ability to write clearly and informatively technical documentation, routine reports, correspondence, procedures and workflows. Presents numerical data effectively. Attention to detail without losing site of the big picture
• Post graduate diploma / master's degree in quality management
• Demonstrated aptitude for process improvement and use of Lean and Six-Sigma resources and tools
• Strong preference for a proven track record of leadership experience in the development of a large, international team, in multiple regions
• Credentialed Clinical professional, Clinician, RN, LNP or equivalent education and experience to support regulatory determinations of potential clinical harms in support of HHE related decision making
• American Society for Quality (ASQ) Certifications - Certified Quality Engineer (CQE) and/or Certified Biomedical Auditor (CBA)
• Regulatory Affairs Certification – RAC (Global)