Post Market Surveillance Specialist (Fixed-Term)
Work Shift:
DAYWork Schedule:
Why Merit?
At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.
This position is a fixed-term opportunity currently expected to run through March 2027.
ESSENTIAL FUNCTIONS PERFORMED
1. Perform complaint investigations and assist with reporting decisions.
2. Interacts with various levels of management, international regulatory affairs/quality assurance, and global regulatory bodies on the adverse event reporting process.
3. Analyzes and makes recommendations regarding complaints received by Merit to determine if they are reportable to global regulatory bodies.
4. Participates in complaint related meetings to determine which complaints require an adverse event report.
5. Performs and reviews complaint investigations and makes recommendations for resolution.
6. Maintains appropriate records for the Global Quality Assurance adverse event reporting system as defined in relevant procedures.
8. Prepares for, participates in and assists with FDA facility inspections, Notified Body Audits, Post Market Surveillance activities and other governmental inspections as directed.
9. Performs other duties and tasks, as needed.
ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS
• Lifting -- Not to exceed 50 lbs. – local practice may apply.
• Writing
• Sitting
• Standing
• Bending
• Visual acuity
• Color perception
• Depth perception
• Reading
• Field of vision/peripheral
SUMMARY OF MINIMUM QUALIFICATIONS
• 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 QUALIFICATIONS
• American Society for Quality (ASQ) Certifications - Certified Quality Auditor (CQA)
• Regulatory Affairs Certification – RAC (Global).
• Experience with electronic submissions.
COMPETENCIES
• Global medical device adverse event reporting, such as MDR, MPR, TGA, and Vigilance
• Computer skills/internet research
• Interpersonal/communication skills
• Quality system development/training
COMMENTS
Infectious Control Risk Category II:
The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category II states employment and procedures that may require exposure.
As an eligible Merit employee, you can expect the following:
* Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights
* 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
To see more on our culture, go to www.merit.com/careers.
Military Veterans are encouraged to Apply.
Merit is a proud Utah Patriot Partner committed to hiring our Veterans.
Apply To This Job
DAYWork Schedule:
Why Merit?
At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.
This position is a fixed-term opportunity currently expected to run through March 2027.
ESSENTIAL FUNCTIONS PERFORMED
1. Perform complaint investigations and assist with reporting decisions.
2. Interacts with various levels of management, international regulatory affairs/quality assurance, and global regulatory bodies on the adverse event reporting process.
3. Analyzes and makes recommendations regarding complaints received by Merit to determine if they are reportable to global regulatory bodies.
4. Participates in complaint related meetings to determine which complaints require an adverse event report.
5. Performs and reviews complaint investigations and makes recommendations for resolution.
6. Maintains appropriate records for the Global Quality Assurance adverse event reporting system as defined in relevant procedures.
8. Prepares for, participates in and assists with FDA facility inspections, Notified Body Audits, Post Market Surveillance activities and other governmental inspections as directed.
9. Performs other duties and tasks, as needed.
ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS
• Lifting -- Not to exceed 50 lbs. – local practice may apply.
• Writing
• Sitting
• Standing
• Bending
• Visual acuity
• Color perception
• Depth perception
• Reading
• Field of vision/peripheral
SUMMARY OF MINIMUM QUALIFICATIONS
• 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 QUALIFICATIONS
• American Society for Quality (ASQ) Certifications - Certified Quality Auditor (CQA)
• Regulatory Affairs Certification – RAC (Global).
• Experience with electronic submissions.
COMPETENCIES
• Global medical device adverse event reporting, such as MDR, MPR, TGA, and Vigilance
• Computer skills/internet research
• Interpersonal/communication skills
• Quality system development/training
COMMENTS
Infectious Control Risk Category II:
The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category II states employment and procedures that may require exposure.
As an eligible Merit employee, you can expect the following:
* Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights
* 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
To see more on our culture, go to www.merit.com/careers.
Military Veterans are encouraged to Apply.
Merit is a proud Utah Patriot Partner committed to hiring our Veterans.
Apply To This Job