Post Market Surveillance Specialist

Overview

Fixed‑term opportunity expected to run through March 2027.

• Perform complaint investigations and assist with reporting decisions.
• Interact with various levels of management, international regulatory affairs/quality assurance, and global regulatory bodies on the adverse event reporting process.
• Analyze and make recommendations regarding complaints received by the company to determine if they are reportable to global regulatory bodies.
• Participate in complaint‑related meetings to determine which complaints require an adverse event report.
• Perform and review complaint investigations and make recommendations for resolution.
• Maintain appropriate records for the Global Quality Assurance adverse event reporting system as defined in relevant procedures.
• Prepare for, participate in, and assist with FDA facility inspections, Notified Body Audits, Post Market Surveillance activities, and other governmental inspections as directed.
• Perform other duties and tasks as needed.

• 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 with spreadsheets, word processing, database, internet research, and other applicable software programs.

• American Society for Quality (ASQ) Certifications – Certified Quality Auditor (CQA).
• Regulatory Affairs Certification – RAC (Global).
• Experience with electronic submissions.

• Global medical device adverse event reporting, such as MDR, MPR, TGA, and Vigilance.
• Computer skills/internet research.
• Interpersonal/communication skills.
• Quality system development/training.