Complaint Specialist (Remote)

The Complaint Specialist will play a critical role in the timely review of complaints to ensure investigations are complete and well documented, and regulatory reporting determination documentation.

This position requires an understanding of Medical Device regulatory obligations for compliance within the scope of the department (E.g., US FDA 21 CFR 820.198, 21 CFR 803, 21 CFR 806, EU MDR, UK Regulations, Health Canada MPR, JPN PMDA Regulations and other global post-market regulatory obligations as required).

Primary responsibilities include, but are not limited to identifying, reviewing and processing complaints for evaluation as required by applicable regulations, standards, and company policy. Assist Customer Support and serve as a liaison for complaint escalations.  Review of complaint investigations and trends. General understanding of CAPA, NCR, and Health Hazard Evaluation and Risk Management.

 Job Responsibilities:

• Assess reports received through multiple customer feedback channels to identify alleged deficiencies
• Ensure accurate documentation, evaluation, reporting determination and investigation results
• Post-market surveillance and vigilance reporting
• Manage timely and compliant complaint records review and closure
• Own the complaint tools and processes with a vision towards process improvement and streamlining
• Provide post-market metrics and data as needed
• Support Quality Management System, as needed
• Ability to work in a fast-paced adaptive environment, self-starter, and strong team player required.
• Assist Customer Support and serve as a liaison for complaint escalations
• Review of complaint investigations and trends. General understanding of CAPA, NCR, Health Hazard Evaluation and Risk Management.

Skills Needed:

• Knowledge of US and International regulatory post-market requirements
• Critical thinking skills and great attention to detail
• Experience with software medical device product preferred
• Experience with EDMS - Electronic Document Management System
• Excellent communication, documentation and time management skills
• Proficient with Salesforce platform preferred
• Proficient with Windows, MS Office, Excel and PowerPoint skills

Educational Requirements & Work Experience: 

• Bachelor’s degree preferred
• 2-5 years’ relevant experience in medical device industry or related experience

This position has an estimated base salary of $65,000-$85,000, cash bonus, and stock options.