Post Market Surveillance Specialist – Fixed-Term

Job not on LinkedIn

🔥 0 minutes ago

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Merit Medical Oncology

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1987

🏥 Healthcare

💼 Consulting

📦 Logistics

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

Healthcare • Consulting • Logistics

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

• Maintain and implement improvement projects and provide training when needed • Interact with management, international regulatory affairs/quality assurance, and global regulatory bodies on adverse event reporting • Analyze complaints and recommend whether they are reportable to global regulatory bodies • Participate in complaint-related meetings to determine which complaints require adverse event reports • Review complaint investigations and recommend resolutions • Prepare and submit reports to global regulatory bodies within required timeframes • Maintain records for the Global Quality Assurance adverse event reporting system • Prepare for, participate in, and assist with FDA facility inspections, Notified Body Audits, Post Market Surveillance activities, and governmental inspections • Perform 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) • Knowledge of the Medical Devices Directive (93/42/EEC, as amended) • Knowledge of European Medical Device Regulation 2017/745 (MDR) • Knowledge of ISO 13485 Quality System Standards • Knowledge of Canadian Medical Device Regulations • Experience with global medical-device adverse-event reporting, including MDR, MPR, Vigilance, and TGA • Self-motivated and self-directing • Strong attention to detail and excellent time-management skills • Strong interpersonal skills and ability to communicate well verbally and in writing • Project-management experience • Demonstrated computer skills, preferably spreadsheets, word processing, databases, internet research, and other applicable software • Preferred: ASQ Certified Quality Auditor (CQA) • Preferred: Regulatory Affairs Certification (RAC Global) • Preferred: Experience with electronic submissions • Ability to meet physical demands including lifting up to 50 lbs., writing, sitting, standing, bending, visual acuity, color perception, depth perception, reading, and peripheral vision

🏖️ 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 • Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights