Post Market Surveillance Specialist (Fixed-Term)

100 Merit Medical Systems, Inc.; California (MO); Hybrid; USD 70,000 - 100,000; Full time

Job summary

Merit Medical Systems, Inc. is seeking a Regulatory Affairs/Quality Assurance professional for a fixed-term role through March 2027. The position involves overseeing global adverse event reporting and complaint management, ensuring regulatory compliance across agencies.

You will prepare submissions, interact with regulators, and support inspections and audits, collaborating with management to maintain the highest standards of quality and patient safety.

Qualifications

• Bachelor’s Degree and 3+ years in Quality/Regulatory field.
• Knowledge of FDA regs (21 CFR 803) and MDR/MDR, ISO 13485.
• Experience with global adverse event reporting for medical devices.
• Strong time management and attention to detail.
• Excellent written and verbal communication.

Responsibilities

• Maintains and implements improvement projects and provides training.
• Interacts with management, regulatory affairs/QA, and global regulatory bodies on adverse event reporting.
• Analyzes complaints to determine reportability to regulators.
• Prepares and submits reports to global regulatory bodies within required timeframes.
• Assists with FDA inspections, Notified Body audits and other governmental inspections.

Skills

Regulatory affairs

Adverse event reporting

Project management

Communication skills

Attention to detail

Education

Bachelor’s Degree in related field

Tools

Regulatory submissions software

Job description

Work Shift: DAY Work 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. Maintains and implements improvement projects and provides training when needed.
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. Reviews complaint investigations and makes recommendations for resolution.
6. Prepares and submits necessary reports to global regulatory bodies within the required timeframe for each agency and report type.
7. 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 & 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.

Merit is a proud Utah Patriot Partner committed to hiring our Veterans.

Founded in 1987, Merit Medical Systems, Inc. is a leading manufacturer and marketer of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy.

Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling in excess of 500 individuals. Merit employs approximately 6,000 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Aliso Viejo, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Ontario, Canada; Melbourne, Australia; Tokyo, Japan; Reading, United Kingdom; Johannesburg, South Africa; and Singapore.

UNDERSTAND. INNOVATE. DELIVER.