Post Market Surveillance Specialist (Fixed-Term)

About the Role

This position is a fixed-term opportunity currently expected to run through March 2027.

Essential Functions

• 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.

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

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

Pay, Schedule & Benefits

• Work Shift: DAY
• Work Schedule: 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