Merit Medical Systems, Inc. · 1 day ago
Post Market Surveillance Specialist
South Jordan, UT
Full-time
Onsite
Mid Level
3+ years expMerit Medical Systems, Inc. is dedicated to creating innovative medical devices that enhance patient lives. The Post Market Surveillance Specialist is responsible for maintaining and implementing improvements in the Global Adverse Event reporting system and assisting with various post market surveillance activities.
Health CareManufacturing
Responsibilities
Maintains and implements improvement projects and provides training when needed
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
Reviews complaint investigations and makes recommendations for resolution
Prepares and submits necessary reports to global regulatory bodies within the required timeframe for each agency and report type
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
Qualification
Required
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
Preferred
American Society for Quality (ASQ) Certifications - Certified Quality Auditor (CQA)
Regulatory Affairs Certification – RAC (Global)
Experience with electronic submissions
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
Company
Merit Medical Systems, Inc.
As a global healthcare company, we understand customer needs and innovate and deliver medical solutions that transform patient care.
5001-10000 employees
H1B Sponsorship
Merit Medical Systems, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (1)
2022 (4)
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.07BKey Investors
Starboard Value
2023-06-07Post Ipo Debt· $850M
2020-01-14Post Ipo Equity
2018-07-31Post Ipo Equity· $217M
Leadership Team
N
Neil Peterson
Chief Operating Officer
R
Robert D. Poser
Vice President, Technology
Recent News
BioWorld Financial Watch
2026-01-11
Columbia West
2025-12-13
Company data provided by crunchbase