Post Market Surveillance Specialist
| Company | Merit Medical Systems |
|---|---|
| Location | South Jordan, UT, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Mid Level |
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), 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.
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.
Preferred Qualifications
- American Society for Quality (ASQ) Certifications – Certified Quality Auditor (CQA)
- Regulatory Affairs Certification – RAC (Global).
- Experience with electronic submissions.