Post Market Surveillance Specialist – Fixed-Term

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

📋 Description

• Oversee and execute enhancement projects while providing training as necessary.

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

• Evaluate complaints and advise on their reportability to global regulatory organizations.

• Engage in meetings related to complaints to identify which require adverse event reporting.

• Assess complaint investigations and suggest appropriate resolutions.

• Compile and submit reports to global regulatory authorities within stipulated timelines.

• Maintain documentation for the Global Quality Assurance adverse event reporting system.

• Prepare for, participate in, and support FDA facility inspections, Notified Body Audits, Post Market Surveillance activities, and governmental inspections.

• Execute additional duties and responsibilities as required.

⛳️ Requirements

• Education and/or experience equivalent to a Bachelor’s Degree along with three years of relevant experience in a Quality/Regulatory-related domain.

• Familiarity with U.S. FDA regulations (21 CFR 803).

• Understanding of the Medical Devices Directive (93/42/EEC, as amended).

• Knowledge of European Medical Device Regulation 2017/745 (MDR).

• Proficiency in ISO 13485 Quality System Standards.

• Awareness of Canadian Medical Device Regulations.

• Experience in global medical-device adverse-event reporting, including MDR, MPR, Vigilance, and TGA.

• Self-driven and capable of independent direction.

• Exceptional attention to detail and strong time-management abilities.

• Excellent interpersonal skills with effective verbal and written communication capabilities.

• Experience in project management.

• Proven computer proficiency, particularly in spreadsheets, word processing, databases, internet research, and other relevant software.

• Preferred: ASQ Certified Quality Auditor (CQA).

• Preferred: Regulatory Affairs Certification (RAC Global).

• Preferred: Experience with electronic submissions.

• Ability to fulfill physical requirements, including lifting up to 50 lbs, writing, sitting, standing, bending, visual acuity, color perception, depth perception, reading, and peripheral vision.

🏝️ Benefits

• Medical/Dental & Other Insurances (eligible the first of the 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.

• Multiple Shifts and Hours available: Days, Swing (Evening), and Nights.