Senior Clinical Post Market Specialist

Merit Medical Systems • South Jordan, UT

12d • Onsite

About The Position

Performs diversified responsibilities in the Post Market Surveillance department. Works with internal and external customers to ensure proper handling and documentation of post market surveillance data. Ensures compliance with quality management sub-systems, provides clinical subject matter expertise to Health Hazard Evaluation (HHE) reports, and makes recommendations for HHE process improvements. Executes assigned Post Market Surveillance (PMS) documentation processes such as Periodic Safety Update Reports (PSUR) and Post Market Surveillance Reports (PMSR). Assists or executes Field Correction Action (FCA) and Recalls, and makes process improvement recommendations. Reviews Risk Management File contents for appropriate harms relative to identified device hazards. Develops, implements, and maintains compliant quality management sub-systems across all Global sites. Develops, implements, and measures key performance metrics. Provides Subject Matter Expertise and Training for evaluating returned medical device products and ascertaining risks to patient safety. Assists in maintaining and establishing PMS Documentation, HHE and Field Corrective Action and Recall systems. Expected to maintain PMS and FCA reporting compliance to all applicable regulation time requirements. Maintains appropriate records for PMS, HHE and FCA reporting systems. Establishes and maintains awareness of relevant regulations and standards. Participates in and leads trend review of events and reports to notified bodies. Coordinates and interacts with management, international regulatory affairs/quality assurance, and global regulatory bodies on adverse event reporting, customer complaints and Global PMS requirements. Leads communication to regulatory authorities, notified bodies, customers, and external entities. Prepares for, participates in, and assists with FDA facility inspections, Notified Body Audits, and other governmental inspections. Drives continuous improvement initiatives based on post-market surveillance findings.

Requirements

• Possess a minimum of a registered nursing (RN) or licensed nurse practitioner (LNP) or equivalent education and experience to support regulatory determinations of potential clinical harms in support of HHE related decision making.
• At least eight (8) years of work-related experience in the medical device industry
• 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.
• Familiarity with process improvement and use of Lean and Six-Sigma resources and tools.
• American Society for Quality (ASQ) Certifications - Certified Quality Engineer (CQE) and/or Certified Biomedical Auditor (CBA)
• Regulatory Affairs Certification – RAC (Global).

Responsibilities

• Provides clinical subject matter expertise to Health Hazard Evaluation (HHE) reports, ensures selected hazards and harms in HHE are accurate and makes overall HHE process improvement recommendations
• Executes assigned Post Market Surveillance (PMS) documentation processes such as Periodic Safety Update Reports (PSUR) and Post Market Surveillance Reports (PMSR)
• Assists or executes any assigned Field Correction Action (FCA) and Recalls and makes process improvement recommendations as requested
• Reviews in process and previously established Risk Management File contents for appropriate harms relative to identified device hazards
• 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.
• Assists in maintaining and establishing Post Market Surveillance Documentation, HHE and Field Corrective Action and Recall systems focused on specific reporting timeliness and consistent, compliant process execution.
• 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 requested, leads timely trend review of serious and non-serious events and reports to notified bodies based on inquiries associated with EU-MDR submissions and/or submitted PMS documentation.
• 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.
• Leads timely, responsive, and evidence-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.

Benefits

• Medical/Dental & Other Insurances (eligible the first of month after 30 days)
• Low Cost Onsite Medical Clinic
• Two (2) Onsite Cafeterias
• Employee Garden | Gardening Classes
• 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays
• 401K | Health Savings Account

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed