Global Post-Market Surveillance Specialist (Fixed-Term)

Merit Medical Systems, Inc.; United States; On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Medical/Dental Insurance

Onsite Medical Clinic

Cafeterias

Gardening Classes

Vacation & Holidays

401K + HSA

Job summary

Merit Medical Systems, Inc. is seeking a Quality/Regulatory professional to support adverse event reporting, regulatory compliance, and quality system processes across global agencies.

The role requires collaboration with management, regulatory affairs, and QA teams to ensure timely, accurate reporting and documentation. The ideal candidate will have a Bachelor's degree (or equivalent), 3 years in a regulatory/quality setting, and strong skills in FDA regulations, MDR/Vigilance, and project

Qualifications

• Bachelor's degree or equivalent with 3 years in Quality/Regulatory field.
• Knowledge of US FDA regulations (21 CFR 803) and MDR/Canadian MDR familiarity.
• Experience with global adverse event reporting for medical devices (MDR, Vigilance, etc.).
• Strong attention to detail and time management skills.
• Excellent written and verbal communication abilities.

Responsibilities

• Maintains and improves quality/regulatory processes and provides training as needed.
• Interacts with management, regulatory affairs, QA, and global regulatory bodies on adverse event reporting.
• Analyzes complaints to determine reportability for global regulatory bodies.
• Participates in meetings to decide which complaints require adverse event reports.
• Reviews investigations and recommends resolutions.

Skills

FDA regulations knowledge

Global adverse event reporting

Project management

Communication skills

Computer skills

Education

Bachelor's Degree or equivalent

Tools

Microsoft Office

Job description

Merit Medical Systems, Inc. is seeking a Quality/Regulatory professional to support adverse event reporting, regulatory compliance, and quality system processes across global agencies.

The role requires collaboration with management, regulatory affairs, and QA teams to ensure timely, accurate reporting and documentation. The ideal candidate will have a Bachelor's degree (or equivalent), 3 years in a regulatory/quality setting, and strong skills in FDA regulations, MDR/Vigilance, and project