Post Market Surveillance Specialist

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🕒 May 26

⛷️ Utah – Remote

⛷️ Utah – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

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Merit Medical Oncology

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1987

🤝 B2B

💰 $4.2M Venture Round - Cianna Medical on 2016-10

B2B

Merit Medical Oncology is a division/specialty of Merit Medical Systems focused on devices and procedural solutions for oncologic interventions. It is part of Merit Medical Systems, a global manufacturer founded in 1987 that designs and markets proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures across cardiology, radiology, oncology, critical care and endoscopy. Merit Medical Oncology supports hospitals and physicians worldwide with products (e. g. , biopsy, embolotherapy, drainage, and other oncology-related interventional tools), clinician education and training, regulatory and product documentation, and global distribution and customer support.

📋 Description

• Perform complaint investigations and assist with reporting decisions. • Interacts with various levels of management, international regulatory affairs/quality assurance, and global regulatory bodies on the adverse event reporting process. • Analyzes and makes recommendations regarding complaints received by Merit to determine if they are reportable to global regulatory bodies. • Participates in complaint related meetings to determine which complaints require an adverse event report. • Performs and reviews complaint investigations and makes recommendations for resolution. • Maintains appropriate records for the Global Quality Assurance adverse event reporting system as defined in relevant procedures. • Prepares for, participates in and assists with FDA facility inspections, Notified Body Audits, Post Market Surveillance activities and other governmental inspections as directed. • Performs other duties and tasks, as needed.

🎯 Requirements

• Education and/or experience equivalent to a Bachelor’s Degree and three years of related experience in a Quality/Regulatory related field. • Knowledge of U.S. FDA regulations (21 CFR 803), 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 Regulations. • Experience with medical device global adverse event reporting required, such as MDR, MPR, and Vigilance, TGA, etc. • Self-motivated, self-directing, strong attention to detail and excellent time management skills. • Strong interpersonal skills and the ability to communicate well – verbally and in writing – with others. • Project management experience. • Demonstrated computer skills preferably spreadsheets, word processing, database, internet research and other applicable software programs.

🏖️ 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