Post Market Surveillance Analyst

Galvanize Therapeutics is a biomedical platform company operating at the convergence of engineering, biology, and healthcare delivery, aiming to deliver life-changing solutions to patients and their doctors. We design and develop Pulsed Electric Field Systems to achieve meaningful and lasting therapeutic outcomes for patients.The Post Market Surveillance Analyst will aid in the continued maintenance and improvement of the Post-Market Surveillance program at Galvanize Therapeutics, specifically the complaint handling system. Work cross-functionally to ensure the complaints and Post-Market Surveillance program continues to function properly and efficiently. Key ResponsibilitiesOversee the complaint handling process, including but not limited to MDR reporting, tracking and trending of complaints, and general oversight of individual complaint investigations. Maintain the PMS plans and reports as necessary. • Oversee complaint handling with Customer Service, including but not limited to determiningreportability of complaints and overall complaint investigation oversight, review and closure.• Support Regulatory in reporting of MDRs to appropriate authorities.• Maintain and improve the complaint tracking and trending process for all Products.• Collect and analyze data necessary for routine reports and updates to executive leadership.• Monitor applicable standards updates and help update documents accordingly.• Support Regulatory and Quality with internal and external audits.Key RequirementsEducation and Training: Bachelor's degree in science, math, or engineering preferred.Skills and Experience: Organized and motivated team player with proficiency in PowerBI, Microsoft Word and Excel. Minimum of 3-5 years' experience in Quality or Regulatory affairs at a Medical Device company or similar industry. Experience with complaint handling and root cause investigations for disposables and/or capital equipment preferred.Other: Hybrid work options available but must be available to work in the office 2-3 days/week. Position Reports To: Sr. Manager, Post-Market Surveillance