Post Market Surveillance Specialist

This is a fully remote position, open to applicants in Utah.

📋 Description

• Conduct investigations into complaints and support decision-making for reporting.

• Collaborate with various management levels, international regulatory affairs/quality assurance, and global regulatory entities regarding the adverse event reporting process.

• Evaluate and provide recommendations on complaints received by Merit to ascertain their reportability to global regulatory authorities.

• Engage in complaint-related meetings to identify which complaints necessitate an adverse event report.

• Execute and review complaint investigations, offering suggestions for resolution.

• Keep accurate records for the Global Quality Assurance adverse event reporting system as stipulated 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 required.

• Carry out additional duties and tasks as necessary.

⛳️ Requirements

• Education and/or experience comparable to a Bachelor’s Degree and three years of relevant experience in a Quality/Regulatory field.

• Familiarity with 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.

• Required experience in global adverse event reporting for medical devices, including MDR, MPR, Vigilance, TGA, etc.

• Self-motivated, proactive, with a keen attention to detail and excellent time management abilities.

• Strong interpersonal skills and effective communication abilities, both verbal and written.

• Experience in project management.

• Proven computer skills, preferably in spreadsheets, word processing, databases, internet research, and other relevant software applications.

🏝️ Benefits

• 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