Manager, Post Market Surveillance

Merit Medical Systems, Inc.

1d•Onsite

About The Position

At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world. ESSENTIAL FUNCTIONS PERFORMED Responsible for Post Market Surveillance (PMS) documentation processes such as Periodic Safety Update Reports (PSUR) and Post Market Surveillance Reports (PMSR), Health Hazard Evaluation (HHE) Processes, and Field Correction Action and Recall (FCA) Processes 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. Expected to maintain 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. May coordinate and interact 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. Supports 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 / Biomedical engineering / science, nursing or equivalent qualification essential (NFQ Level 7, or higher).
At least eight (8) years of work-related experience in the medical device industry, of which a five 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.

Nice To Haves

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).

Responsibilities

Responsible for Post Market Surveillance (PMS) documentation processes such as Periodic Safety Update Reports (PSUR) and Post Market Surveillance Reports (PMSR), Health Hazard Evaluation (HHE) Processes, and Field Correction Action and Recall (FCA) Processes
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.
Expected to maintain 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.
May coordinate and interact 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.
Supports 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.