Sign in

Regulatory Affairs I (Complaint handling/ MDR submissions)

Company:
LanceSoft INC
Location:
West Chester, Pennsylvania, United States
Posted:
April 10, 2019

Description:

Description:

•Customer Quality member responsible for supporting Post Market Regulatory Affairs activities associated with complaint handling and MDR submissions.

•These activities include intake, investigation, documentation, follow-up, regulatory reporting and metrics.

•The Customer Quality Specialist is responsible for the oversight and direct support of technical evaluations and investigational tasks required for complaint processing/ closure.

•The Customer Quality Specialist works collaboratively with Quality, Engineering, Manufacturing, Product Development and other functional experts.

Duties:

•Responsible and accountable for on-time submission and accuracy of regulatory reports

•Review and complete determination associated Medical Device Report and/or Vigilance Report

•Knowledge of and familiarity with global regulations for reporting

•Directly interface with service centers, Hospitals, Surgeons, and Internal employees for reporting of complaints and adverse events

•Interact positively with internal, external business partners and colleagues

•Adhere and comply to work instructions, standard operating procedures, and regulations

•Expedite investigations by collaborating with internal/external business partners

•Achieve productivity targets

•Fully trained within three months of hire

•Achieve accuracy targets for complaint documentations

•Participate in projects and events

•Complaint determination

•Reportability assessments

•Conduct follow-ups with complainant, reporters

•Checking your own work

•Updating SharePoint

•Tracking complaints in the process for closure

•All other duties as assigned

Professional Experience Requirements:

•Ability to work in a cross-functional matrix environment

•Active listening/ phone skills

•Collaboration and teaming skills

•Critical thinking skills

•Detail orientation

•Organization skills

•Prioritization and multi-tasking skills

•Strong verbal and written communication skills

•Knowledge of basic medical terminology

•Proficiency in MS Office (Word, Excel, Outlook, PowerPoint, Sharepoint)

•Continuous learner

•Global mindset

•Accountability for own work

•Problem solving/Root cause analysis skills

Educational Requirements:

• Bachelor’s Degree or equivalent experience

• Generally requires 2-4 years of related work experience

• RAC or ASQ certifications a plus